Delsym

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Delsym Recall

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Side Effects & Adverse Reactions

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

chronic cough that lasts as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if you have

chronic cough that lasts as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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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 relieves

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the impulse to cough to help you get to sleep

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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

Delsym Manufacturers

Reckitt Benckiser Llc

Delsym | Reckitt Benckiser Llc

shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall
Reckitt Benckiser Llc

Delsym | Reckitt Benckiser Llc

shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall
Reckitt Benckiser, Inc.

Delsym | Reckitt Benckiser, Inc.

shake bottle well before use dose as follows or as directed by a doctor. adults and children 12 years of age and over 2 teaspoonfuls every 12 hours, not to exceed 4 teaspoonfuls in 24 hours children 6 to under 12 years of age 1 teaspoonful every 12 hours, not to exceed 2 teaspoonfuls in 24 hours children 4 to under 6 years of age 1/2 teaspoonful every 12 hours, not to exceed 1 teaspoonful in 24 hours children under 4 years of age do not use

No Recall
Reckitt Benckiser, Inc.

Delsym | Reckitt Benckiser, Inc.

do not take more than directed do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Age (year) Dose (mL) adults and children 12 years of age and over 10 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use

No Recall
Reckitt Benckiser, Inc.

Delsym | Reckitt Benckiser, Inc.

do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Adults and Children 12 years and older: 30 mL in dosing cup provided every 4 hours. Children under 12 years of age: Do not use.

No Recall
Rebel Distributors Corp

Delsym | Rebel Distributors Corp

Directions

• shake bottle well before use

• measure only with dosing cup provided. Do not use dosing cup with other products.

• dose as follows or as directed by a doctor

adults and children 12 years of age and over

10 mL every 12 hours,

not to exceed 20 mL in 24 hours

children 6 to under 12 years of age

5 mL every 12 hours,

not to exceed 10 mL in 24 hours

children 4 to under 6 years of age

2.5 mL every 12 hours,

not to exceed 5 mL in 24 hours

children under 4 years of age do not use

Other information

• each 5 mL contains: sodium 7 mg

• store at 20°-25°C (68°-77°F)

• dosing cup provided

Drug Facts

Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009

No Recall
Physicians Total Care, Inc.

Delsym | Physicians Total Care, Inc.

shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours,
not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall
A-s Medication Solutions Llc

Delsym | A-s Medication Solutions Llc

shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours,
not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall
Reckitt Benckiser Llc

Delsym | Sagent Pharmaceuticals

2.1 Adult Population
The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intramuscularly (IM) or intravenously (IV) over approximately 30 minutes.
Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.
* In rare instances, doses of up to 12 grams of cefazolin per day have been used.
Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours 2.2 Perioperative Prophylactic Use
To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:
1 gram IV or IM administered ½ hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.
It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.
2.3 Patients with Renal Impairment
Cefazolin for Injection may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.
Table 2: Dosage Adjustment for Patients with Renal Impairment Creatinine Clearance Dose Frequency 55 mL/min. or greater full dose normal frequency 35 to 54 mL/min. full dose every 8 hours or longer 11 to 34 mL/min. 1/2 usual dose every 12 hours 10 mL/min. or less 1/2 usual dose every 18 to 24 hours 2.4 Pediatric Dosage
In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.
Table 3: Pediatric Dosage Guide
Weight 25 mg/kg/day
Divided into 3 Doses 25 mg/kg/day
Divided into 4 Doses

Lbs

Kg
Approximate Single Dose mg/q 8 h Vol. (mL) needed with dilution of
125 mg/mL
Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of
125 mg/mL 10
20
30
40
50 4.5
9
13.6
18.1
22.7 40 mg
75 mg
115 mg
150 mg
190 mg 0.35 mL
0.6 mL
0.9 mL
1.2 mL
1.5 mL 30 mg
55 mg
85 mg
115 mg
140 mg 0.25 mL
0.45 mL
0.7 mL
0.9 mL
1.1 mL
Weight 50 mg/kg/day
Divided into 3 Doses 50 mg/kg/day
Divided into 4 Doses

Lbs

Kg
Approximate Single Dose mg/q 8 h Vol. (mL) needed with dilution of
225 mg/mL
Approximate Single Dose mg/q 6 h Vol. (mL) needed with dilution of
225 mg/mL 10
20
30
40
50 4.5
9
13.6
18.1
22.7 75 mg
150 mg
225 mg
300 mg
375 mg 0.35 mL
0.7 mL
1 mL
1.35 mL
1.7 mL 55 mg
110 mg
170 mg
225 mg
285 mg 0.25 mL
0.5 mL
0.75 mL
1 mL
1.25 mL
In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
2.5 Preparation for Use of Cefazolin for Injection
Reconstitution

Preparation of Parenteral Solution

Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Single-Dose Vials

For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.
Table 4: Reconstitution Instructions
Vial Size Amount of Diluent Approximate
Concentration Approximate
Available Volume 500 mg 2 mL 225 mg/mL 2.2 mL 1 gram 2.5 mL 330 mg/mL 3 mL
Administration

Intramuscular Administration

Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

Intravenous Administration

Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:
Sodium Chloride Injection, USP 5% or 10% Dextrose Injection, USP 5% Dextrose in Lactated Ringer's Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.2% Sodium Chloride Injection, USP Lactated Ringer's Injection, USP Invert Sugar 5% or 10% in Sterile Water for Injection Ringer's Injection, USP 5% Sodium Bicarbonate Injection, USP
Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

No Recall
Reckitt Benckiser Llc

Delsym | Amneal Pharmaceuticals Of New York, Llc

use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms;
do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 56 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.

No Recall
Reckitt Benckiser Llc

Delsym | Reckitt Benckiser Llc

shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours,
not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall
Reckitt Benckiser Llc

Delsym | Reckitt Benckiser Llc

shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products. dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours,
not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours,
not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours,
not to exceed 5 mL in 24 hours children under 4 years of age do not use

No Recall