Pain Relief Childrens

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Side Effects & Adverse Reactions

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage (see overdose warning)

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.<</html>

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.<</html>

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

temporarily reduces fever
temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Pain Relief Childrens Manufacturers

Dolgencorp, Inc. (Dollar General & Rexall)

Pain Relief Childrens | Dolgencorp, Inc. (dollar General & Rexall)

this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning) shake well before using mL= milliliter; tsp= teaspoon use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose, use age. Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 ask a doctor 24-35 2-3 5 mL (1 tsp) 36-47 4-5 7.5 ml (1 1/2 tsp) 48-59 6-8 10 mL (2 tsp) 60-71 9-10 12.5 mL (2 1/2 tsp) 72-95 11 15 mL (3 tsp)

No Recall
Medicine Shoppe International Inc

Pain Relief Childrens | Medicine Shoppe International Inc

do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor this product does not contain directions or complete warnings for adult use Weight(lb) Age(yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1 tsp or 5 mL 36–47 4–5 years 1 1/2 tsp or 7.5 mL 48–59 6–8 years 2 tsp or 10 mL 60-71 9–10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Walgreen Company

Pain Relief Childrens | Walgreen Company

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight(lb) Age(yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1 tsp or 5 mL 36–47 4–5 years 1 1/2 tsp or 7.5 mL 48–59 6–8 years 2 tsp or 10 mL 60-71 9–10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Meijer Distribution Inc

Pain Relief Childrens | Meijer Distribution Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1 tsp or 5 mL 36-47 4-5 years 1 1/2 tsp or 7.5 mL 48-59 6-8 years 2 tsp or 10 mL 60-71 9-10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Walgreen Company

Pain Relief Childrens | Walgreen Company

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1 tsp or 5 mL 36-47 4-5 years 1 1/2 tsp or 7.5 mL 48-59 6-8 years 2 tsp or 10 mL 60-71 9-10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Walgreen Company

Pain Relief Childrens | Walgreen Company

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight(lb) Age(yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1 tsp or 5 mL 36–47 4–5 years 1 1/2 tsp or 7.5 mL 48–59 6–8 years 2 tsp or 10 mL 60-71 9–10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Cvs Pharmacy

Pain Relief Childrens | Cvs Pharmacy

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight(lb) Age(yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1 tsp or 5 mL 36–47 4–5 years 1 1/2 tsp or 7.5 mL 48–59 6–8 years 2 tsp or 10 mL 60-71 9–10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kroger Company

Pain Relief Childrens | Kroger Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor
Weight (lb)

Age (yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2-3 years

1 tsp or 5 mL

36-47

4-5 years

1 1/2 tsp or 7.5 mL

48-59

6-8 years

2 tsp or 10 mL

60-71

9-10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kroger Company

Pain Relief Childrens | Kroger Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor
Weight (lb)

Age (yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2-3 years

1 tsp or 5 mL

36-47

4-5 years

1 1/2 tsp or 7.5 mL

48-59

6-8 years

2 tsp or 10 mL

60-71

9-10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kroger Company

Pain Relief Childrens | Kroger Company

• this product does not contain directions or complete warnings for adult use • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than directed (see Liver warning) • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor
Weight (lb)

Age (yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2-3 years

1 tsp or 5 mL

36-47

4-5 years

1 1/2 tsp or 7.5 mL

48-59

6-8 years

2 tsp or 10 mL

60-71

9-10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kroger Company

Pain Relief Childrens | Kroger Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor
Weight (lb)

Age (yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2–3 years

1 tsp or 5 mL

36–47

4–5 years

1 1/2 tsp or 7.5 mL

48–59

6–8 years

2 tsp or 10 mL

60-71

9–10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kroger Company

Pain Relief Childrens | Kroger Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor
Weight(lb)

Age(yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2–3 years

1 tsp or 5 mL

36–47

4–5 years

1 1/2 tsp or 7.5 mL

48–59

6–8 years

2 tsp or 10 mL

60-71

9–10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Hyvee Inc

Pain Relief Childrens | Actavis Pharma, Inc.

2.1 General Dosing Recommendations Ropinirole extended-release tablets are taken once daily, with or without food [see Clinical Pharmacology (12.3)]. Tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease
The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, based on therapeutic response and tolerability. The maximum recommended dose of ropinirole extended-release tablets is 24 mg/day.

In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual patient therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Monitor patients during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical trials, specific dose-response information could not be determined.

Ropinirole extended-release tablets should be discontinued gradually over a 7-day period.

Renal Impairment
No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole extended-release tablets for patients with end-stage renal disease on hemodialysis is 2 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole extended-release tablets in patients with severe renal impairment without regular dialysis has not been studied.
2.3 Switching from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets
Patients may be switched directly from immediate-release ropinirole tablets to ropinirole extended-release tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets, as shown in Table 1.
Table 1. Conversion from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets Immediate-Release Ropinirole Tablets Ropinirole Extended-Release Tablets Total Daily Dose (mg) Total Daily Dose (mg) 0.75 to 2.25 2 3 to 4.5 4 6 6 7.5 to 9 8 12 12 15 16 18 18 21 20 24 24
Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].
2.4 Effect of Gastrointestinal Transit Time on Medication Release
Ropinirole extended-release tablets are designed to release medication over a 24-hour period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication and medication residue being passed in the stool.

No Recall
Cvs Pharmacy

Pain Relief Childrens | Cvs Pharmacy

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor
Weight(lb)

Age(yr)

Dose (tsp or mL)

under 24

under 2 years

ask a doctor

24-35

2–3 years

1 tsp or 5 mL

36–47

4–5 years

1 1/2 tsp or 7.5 mL

48–59

6–8 years

2 tsp or 10 mL

60-71

9–10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Hyvee Inc

Pain Relief Childrens | Foshan Nanhai Jinxiong Toys C O., Ltd

Directions
Rub a dime sized drop into hands. For children under 6 use under adult supervision.

No Recall
Hyvee Inc

Pain Relief Childrens | Mylan Institutional Llc

ULTIVA is for IV use only. Continuous infusions of ULTIVA should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of infusion.
During General Anesthesia
ULTIVA is not recommended as the sole agent in general anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. ULTIVA is synergistic with other anesthetics; therefore, clinicians may need to reduce doses of thiopental, propofol, isoflurane, and midazolam by up to 75% with the coadministration of ULTIVA. The administration of ULTIVA must be individualized based on the patient's response.

Table 10 summarizes the recommended doses in adult patients, predominately ASA physical status I, II, or III.
Table 10: Dosing Guidelines in Adults — General Anesthesia and Continuing as an Analgesic into the Postoperative Care Unit or Intensive Care Setting* Phase Continuous IV Infusion of ULTIVA (mcg/kg/min) Infusion Dose Range of ULTIVA (mcg/kg/min) Supplemental IV Bolus Dose of ULTIVA (mcg/kg) * An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
Induction of Anesthesia
  (through intubation)

0.5 - 1*

Maintenance of anesthesia with:

  Nitrous oxide (66%)

0.4

0.1 - 2

1

  Isoflurane (0.4 to 1.5 MAC)

0.25

0.05 - 2

1

  Propofol
    (100 to 200 mcg/kg/min)

0.25

0.05 - 2

1

Continuation as an analgesic into the immediate postoperative period

0.1

0.025 - 0.2

not recommended

Table 11 summarizes the recommended doses in pediatric patients, predominantly ASA physical status I, II, or III. In pediatric patients, remifentanil was administered with nitrous oxide or nitrous oxide in combination with halothane, sevoflurane, or isoflurane.
Table 11: Dosing Guidelines in Pediatric Patients — Maintenance of Anesthesia Phase Continuous IV
Infusion of ULTIVA
(mcg/kg/min) Infusion Dose
Range of ULTIVA
(mcg/kg/min) Supplemental IV
Bolus Dose of
ULTIVA(mcg/kg) * An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds. † The initial maintenance infusion regimen of Ultiva evaluated in full term pediatric patients from birth to 2 months of age undergoing pyloromyotomy was 0.4 mcg/kg/min, the approved adult regimen for use with N 2O. The clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. Therefore, while a starting infusion of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated. The use of atropine may blunt the potential for bradycardia that can occur upon administration of Ultiva. (See CLINICAL PHARMACOLOGY: Special Populations: Pediatric Patients, and DOSAGE AND ADMINISTRATION, During Maintenance of Anesthesia). ‡ Boluses of 1 mcg/kg were studied in ASA 1 and 2, full-term patients weighing at least 2500 gm, undergoing pyloromyotomy who received pretreatment with atropine. Some neonates, particularly those receiving supplementation with potent inhalation agents or neuraxial anesthesia, those with significant co-morbidities or undergoing significant fluid shifts, or those who have not been pretreated with atropine, may require smaller bolus doses to avoid hypotension and/or bradycardia.
*Maintenance of anesthesia in patients aged 1 to 12 years old with:







  Halothane (0.3 to 1.5 MAC)

0.25

0.05 - 1.3

1

  Sevoflurane (0.3 to 1.5 MAC)

0.25

0.05 - 1.3

1

  Isoflurane (0.4 to 1.5 MAC)

0.25

0.05 - 1.3

1

Maintenance of anesthesia for patients from birth to 2 months of age with:







  Nitrous oxide (70%)†

0.4

0.4 - 1.0

1‡
During Induction of Anesthesia
ULTIVA should be administered at an infusion rate of 0.5 to 1 mcg/kg/min with a hypnotic or volatile agent for the induction of anesthesia. If endotracheal intubation is to occur less than 8 minutes after the start of the infusion of ULTIVA, then an initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
During Maintenance of Anesthesia
After endotracheal intubation, the infusion rate of ULTIVA should be decreased in accordance with the dosing guidelines in Tables 10 (adults) and 11 (pediatric patients). Due to the fast onset and short duration of action of ULTIVA, the rate of administration during anesthesia can be titrated upward in 25% to 100% increments in adult patients or up to 50% increments in pediatric patients, or downward in 25% to 50% decrements every 2 to 5 minutes to attain the desired level of µ-opioid effect. In response to light anesthesia or transient episodes of intense surgical stress, supplemental bolus doses of 1 mcg/kg may be administered every 2 to 5 minutes. At infusion rates >1 mcg/kg/min, increases in the concomitant anesthetic agents should be considered to increase the depth of anesthesia. See CLINICAL PHARMACOLOGY: Special Populations: Pediatric Patients, and DOSAGE AND ADMINISTRATION, Table 11 for additional information.
Continuation as an Analgesic into the Immediate Postoperative Period Under the Direct Supervision of an Anesthesia Practitioner
Infusions of ULTIVA may be continued into the immediate postoperative period for select patients for whom later transition to longer acting analgesics may be desired. The use of bolus injections of ULTIVA to treat pain during the postoperative period is not recommended. When used as an IV analgesic in the immediate postoperative period, ULTIVA should be initially administered by continuous infusion at a rate of 0.1 mcg/kg/min. The infusion rate may be adjusted every 5 minutes in 0.025-mcg/kg/min increments to balance the patient's level of analgesia and respiratory rate. Infusion rates greater than 0.2 mcg/kg/min are associated with respiratory depression (respiratory rate less than 8 breaths/min).
Guidelines for Discontinuation
Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later time.

Due to the rapid offset of action of ULTIVA, no residual analgesic activity will be present within 5 to 10 minutes after discontinuation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, alternative analgesics should be administered prior to discontinuation of ULTIVA. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of follow-up care (see CLINICAL TRIALS).
Analgesic Component of Monitored Anesthesia Care
It is strongly recommended that supplemental oxygen be supplied to the patient whenever ULTIVA is administered.

Table 12 summarizes the recommended doses for monitored anesthesia care in adult patients, predominately ASA physical status I, II, or III. ULTIVA has not been studied for use in children in monitored anesthesia care.
Table 12: Dosing Guidelines in Adults — Monitored Anesthesia Care Method Timing ULTIVA Alone ULTIVA + 2 mg Midazolam
Single IV Dose

Given 90 seconds before local anesthetic

1 mcg/kg over
30 to 60 seconds

0.5 mcg/kg over
30 to 60 seconds

Continuous IV Infusion

Beginning 5 minutes before local anesthetic

0.1 mcg/kg/min

0.05 mcg/kg/min

After local anesthetic

0.05 mcg/kg/min
(Range: 0.025 -
0.2 mcg/kg/min)

0.025 mcg/kg/min
(Range: 0.025 -
0.2 mcg/kg/min)
Single Dose
A single IV dose of 0.5 to 1 mcg/kg over 30 to 60 seconds of ULTIVA may be given 90 seconds before the placement of the local or regional anesthetic block (see PRECAUTIONS).
Continuous Infusion
When used alone as an IV analgesic component of monitored anesthesia care, ULTIVA should be initially administered by continuous infusion at a rate of 0.1 mcg/kg/min beginning 5 minutes before placement of the local or regional anesthetic block. Because of the risk for hypoventilation, the infusion rate of ULTIVA should be decreased to 0.05 mcg/kg/min following placement of the block. Thereafter, rate adjustments of 0.025 mcg/kg/min at 5-minute intervals may be used to balance the patient's level of analgesia and respiratory rate. Rates greater than 0.2 mcg/kg/min are generally associated with respiratory depression (respiratory rates less than 8 breaths/min). Bolus doses of ULTIVA administered simultaneously with a continuous infusion of ULTIVA to spontaneously breathing patients are not recommended.
Individualization of Dosage Use in Geriatric Patients
The starting doses of ULTIVA should be decreased by 50% in elderly patients (>65 years). ULTIVA should then be cautiously titrated to effect.
Use in Pediatric Patients
See Table 11 for dosing recommendations for use of ULTIVA in pediatric patients from birth to 12 years of age for maintenance of anesthesia. See CLINICAL PHARMACOLOGY: Special Populations: Pediatric Patients, and DOSAGE AND ADMINISTRATION, Table 11 and During Maintenance of Anesthesia for additional information.

ULTIVA has not been studied in pediatric patients for use in the immediate postoperative period or for use as a component of monitored anesthesia care.
Use in Coronary Artery Bypass Surgery
Table 13 summarizes the recommended doses for induction, maintenance, and continuation as an analgesic into the ICU in adult patients, predominantly ASA physical status III or IV. To avoid hypotension during the induction phase, it is important to consider the concomitant medication regimens described in the CLINICAL TRIALS: Coronary Artery Bypass Surgery subsection.
Table 13: Dosing Recommendations* — Coronary Artery Bypass Surgery Phase Continuous IV
Infusion of ULTIVA
(mcg/kg/min) Infusion Dose
Range of ULTIVA
(mcg/kg/min) Supplemental
IV Bolus Dose of
ULTIVA (mcg/kg) * See CLINICAL TRIALS: Coronary Artery Bypass Surgery subsection for concomitant medication regimens.
Induction of Anesthesia
(through intubation)

1

Maintenance of Anesthesia

1

0.125 - 4

0.5 - 1

Continuation as an
analgesic into ICU

1

0.05 - 1
Use in Obese Patients
The starting doses of ULTIVA should be based on ideal body weight (IBW) in obese patients (greater than 30% over their IBW).
Preanesthetic Medication
The need for premedication and the choice of anesthetic agents must be individualized. In clinical studies, patients who received ULTIVA frequently received a benzodiazepine premedication.
Preparation for Administration
To reconstitute solution, add 1 mL of diluent per mg of remifentanil. Shake well to dissolve. When reconstituted as directed, the solution contains approximately 1 mg of remifentanil activity per 1 mL. ULTIVA should be diluted to a recommended final concentration of 20, 25, 50, or 250 mcg/mL prior to administration (see Table 14). ULTIVA should not be administered without dilution.
Table 14: Reconstitution and Dilution of ULTIVA Final Concentration Amount of ULTIVA in Each Vial Final Volume After Reconstitution and Dilution
20 mcg/mL

1 mg

50 mL

2 mg

100 mL

5 mg

250 mL

25 mcg/mL

1 mg

40 mL

2 mg

80 mL

5 mg

200 mL

50 mcg/mL

1 mg

20 mL

2 mg

40 mL

5 mg

100 mL

250 mcg/mL

5 mg

20 mL

Continuous IV infusions of ULTIVA should be administered only by an infusion device. Infusion rates of ULTIVA can be individualized for each patient using Table 15:
Table 15: IV Infusion Rates of ULTIVA (mL/kg/h) Drug Delivery Rate
(mcg/kg/min) Infusion Delivery Rate (mL/kg/h) 20 mcg/mL 25 mcg/mL 50 mcg/mL 250 mcg/mL
0.0125

0.038

0.03

0.015

not recommended

0.025

0.075

0.06

0.03

not recommended

0.05

0.15

0.12

0.06

0.012

0.075

0.23

0.18

0.09

0.018

0.1

0.3

0.24

0.12

0.024

0.15

0.45

0.36

0.18

0.036

0.2

0.6

0.48

0.24

0.048

0.25

0.75

0.6

0.3

0.06

0.5

1.5

1.2

0.6

0.12

0.75

2.25

1.8

0.9

0.18

1.0

3.0

2.4

1.2

0.24

1.25

3.75

3.0

1.5

0.3

1.5

4.5

3.6

1.8

0.36

1.75

5.25

4.2

2.1

0.42

2.0

6.0

4.8

2.4

0.48

When ULTIVA is used as an analgesic component of monitored analgesia care, a final concentration of 25 mcg/mL is recommended. When ULTIVA is used for pediatric patients 1 year of age and older, a final concentration of 20 or 25 mcg/mL is recommended. Table 16 is a guideline for milliliter-per-hour delivery for a solution of 20 mcg/mL with an infusion device.
Table 16: IV Infusion Rates of ULTIVA (mL/h) for a 20-mcg/mL Solution Infusion Rate
(mcg/kg/min) Patient Weight (kg) 5 10 20 30 40 50 60
0.0125

0.188

0.375

0.75

1.125

1.5

1.875

2.25

0.025

0.375

0.75

1.5

2.25

3.0

3.75

4.5

0.05

0.75

1.5

3.0

4.5

6.0

7.5

9.0

0.075

1.125

2.25

4.5

6.75

9.0

11.25

13.5

0.1

1.5

3.0

6.0

9.0

12.0

15.0

18.0

0.15

2.25

4.5

9.0

13.5

18.0

22.5

27.0

0.2

3.0

6.0

12.0

18.0

24.0

30.0

36.0

0.25

3.75

7.5

15.0

22.5

30.0

37.5

45.0

0.3

4.5

9.0

18.0

27.0

36.0

45.0

54.0

0.35

5.25

10.5

21.0

31.5

42.0

52.5

63.0

0.4

6.0

12.0

24.0

36.0

48.0

60.0

72.0

Table 17 is a guideline for milliliter-per-hour delivery for a solution of 25 mcg/mL with an infusion device.
Table 17: IV Infusion Rates of ULTIVA (mL/h) for a 25-mcg/mL Solution Infusion Rate
(mcg/kg/min) Patient Weight (kg) 10 20 30 40 50 60 70 80 90 100
0.0125

0.3

0.6

0.9

1.2

1.5

1.8

2.1

2.4

2.7

3.0

0.025

0.6

1.2

1.8

2.4

3.0

3.6

4.2

4.8

5.4

6.0

0.05

1.2

2.4

3.6

4.8

6.0

7.2

8.4

9.6

10.8

12.0

0.075

1.8

3.6

5.4

7.2

9.0

10.8

12.6

14.4

16.2

18.0

0.1

2.4

4.8

7.2

9.6

12.0

14.4

16.8

19.2

21.6

24.0

0.15

3.6

7.2

10.8

14.4

18.0

21.6

25.2

28.8

32.4

36.0

0.2

4.8

9.6

14.4

19.2

24.0

28.8

33.6

38.4

43.2

48.0

Table 18 is a guideline for milliliter-per-hour delivery for a solution of 50 mcg/mL with an infusion device.
Table 18: IV Infusion Rates of ULTIVA (mL/h) for a 50-mcg/mL Solution Infusion Rate
(mcg/kg/min) Patient Weight (kg) 30 40 50 60 70 80 90 100
0.025

2.1

2.4

2.7

3.0

0.05

2.4

3.0

3.6

4.2

4.8

5.4

6.0

0.075

2.7

3.6

4.5

5.4

6.3

7.2

8.1

9.0

0.1

3.6

4.8

6.0

7.2

8.4

9.6

10.8

12.0

0.15

5.4

7.2

9.0

10.8

12.6

14.4

16.2

18.0

0.2

7.2

9.6

12.0

14.4

16.8

19.2

21.6

24.0

0.25

9.0

12.0

15.0

18.0

21.0

24.0

27.0

30.0

0.5

18.0

24.0

30.0

36.0

42.0

48.0

54.0

60.0

0.75

27.0

36.0

45.0

54.0

63.0

72.0

81.0

90.0

1.0

36.0

48.0

60.0

72.0

84.0

96.0

108.0

120.0

1.25

45.0

60.0

75.0

90.0

105.0

120.0

135.0

150.0

1.5

54.0

72.0

90.0

108.0

126.0

144.0

162.0

180.0

1.75

63.0

84.0

105.0

126.0

147.0

168.0

189.0

210.0

2.0

72.0

96.0

120.0

144.0

168.0

192.0

216.0

240.0

Table 19 is a guideline for milliliter-per-hour delivery for a solution of 250 mcg/mL with an infusion device.
Table 19: IV Infusion Rates of ULTIVA (mL/h) for a 250-mcg/mL Solution Infusion Rate
(mcg/kg/min) Patient Weight (kg) 30 40 50 60 70 80 90 100
0.1

0.72

0.96

1.20

1.44

1.68

1.92

2.16

2.40

0.15

1.08

1.44

1.80

2.16

2.52

2.88

3.24

3.60

0.2

1.44

1.92

2.40

2.88

3.36

3.84

4.32

4.80

0.25

1.80

2.40

3.00

3.60

4.20

4.80

5.40

6.00

0.5

3.60

4.80

6.00

7.20

8.40

9.60

10.80

12.00

0.75

5.40

7.20

9.00

10.80

12.60

14.40

16.20

18.00

1.0

7.20

9.60

12.00

14.40

16.80

19.20

21.60

24.00

1.25

9.00

12.00

15.00

18.00

21.00

24.00

27.00

30.00

1.5

10.80

14.40

18.00

21.60

25.20

28.80

32.40

36.00

1.75

12.60

16.80

21.00

25.20

29.40

33.60

37.80

42.00

2.0

14.40

19.20

24.00

28.80

33.60

38.40

43.20

48.00

No Recall
Cvs Pharmacy

Pain Relief Childrens | Cvs Pharmacy

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours
Weight(lb)

Age(yr)

Dose (mL or tsp)*

under 24

under 2 years

ask a doctor

24-35

2–3 years

5 mL (1 tsp)

36–47

4–5 years

7.5 mL ( 1 ½ tsp)

48–59

6–8 years

10 mL (2 tsp)

60-71

9–10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Western Family Foods Inc

Pain Relief Childrens | Gilead Sciences, Inc.

2.1 Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)
For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.

In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established.In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established.
2.2 Dose Adjustment for Renal Impairment in Adults
Significantly increased drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment [See Clinical Pharmacology (12.3)] . Therefore, the dosing interval of VIREAD should be adjusted in patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)] .

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment . No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment [See Warnings and Precautions (5.3)] .
Table 1 Dosage Adjustment for Patients with Altered Creatinine Clearance Creatinine Clearance
(mL/min) * Hemodialysis Patients ≥50 30–49 10–29 * Calculated using ideal (lean) body weight. † Generally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. VIREAD should be administered following completion of dialysis. Recommended 300 mg Dosing Interval Every 24 hours Every 48 hours Every 72 to 96 hours Every 7 days or after a total of approximately 12 hours of dialysis †
The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients.The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients.

No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.

No Recall
Publix Super Markets Inc

Pain Relief Childrens | Unit Dose Services

2.1 General Considerations
Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate tablets for oral use, and should continue this diet during treatment with Fenofibrate tablets for oral use. Fenofibrate tablets for oral use can be given without regard to meals.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenofibrate tablets for oral use if lipid levels fall significantly below the targeted range.

Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.
2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia
The initial dose of Fenofibrate tablets for oral use is 145 mg once daily.
2.3 Severe Hypertriglyceridemia
The initial dose is 48 to 145 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 145 mg once daily.
2.4 Impaired Renal Function
Treatment with Fenofibrate tablets for oral use should be initiated at a dose of 48 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Fenofibrate tablets for oral use should be avoided in patients with severe renal impairment . [see Use in Specific Populations and Clinical Pharmacology ] (8.6)(12.3)
2.5 Geriatric Patients
Dose selection for the elderly should be made on the basis of renal function . [see Use in Specific Populations ] (8.5)
2.5 Geriatric Patients
Dose selection for the elderly should be made on the basis of renal function . [see Use in Specific Populations ] (8.5)

No Recall