Ibuprofen Infants

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Ibuprofen Infants Recall

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Side Effects & Adverse Reactions

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

•: hives
•: facial swelling
•: asthma (wheezing)
•: shock
•: skin reddening
•: rash
•: blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if your child:

•: has had stomach ulcers or bleeding problems
•: takes a blood thinning (anticoagulant) or steroid drug
•: takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
•: takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

•: if the child has ever had an allergic reaction to any other pain reliever/fever reducer
•: right before or after heart surgery

Ask a doctor before use if

•: stomach bleeding warning applies to your child
•: child has a history of stomach problems, such as heartburn
•: child has problems or serious side effects from taking pain relievers or fever reducers
•: child has not been drinking fluids
•: child has lost a lot of fluid due to vomiting or diarrhea
•: child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
•: child has asthma
•: child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

•: under a doctor’s care for any serious condition
•: taking any other drug

When using this product

•: give with food or milk if stomach upset occurs
•: the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

•: child experiences any of the following signs of stomach bleeding:
•: feels faint
•: vomits blood
•: has bloody or black stools
•: has stomach pain that does not get better
•: the child does not get any relief within first day (24 hours) of treatment
•: fever or pain gets worse or lasts more than 3 days
•: redness or swelling is present in the painful area
•: any new symptoms appear

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do not use

•: if the child has ever had an allergic reaction to any other pain reliever/fever reducer
•: right before or after heart surgery

Ask a doctor before use if

•: stomach bleeding warning applies to your child
•: child has a history of stomach problems, such as heartburn
•: child has problems or serious side effects from taking pain relievers or fever reducers
•: child has not been drinking fluids
•: child has lost a lot of fluid due to vomiting or diarrhea
•: child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
•: child has asthma
•: child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

•: under a doctor’s care for any serious condition
•: taking any other drug

Stop use and ask a doctor if

•: child experiences any of the following signs of stomach bleeding:
•: feels faint
•: vomits blood
•: has bloody or black stools
•: has stomach pain that does not get better
•: the child does not get any relief within first day (24 hours) of treatment
•: fever or pain gets worse or lasts more than 3 days
•: redness or swelling is present in the painful area
•: any new symptoms appear

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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:

•: reduces fever
•: relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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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

Ibuprofen Infants Manufacturers

H E B

Ibuprofen Infants | H E B

• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day
Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

No Recall
Western Family Foods Inc

Ibuprofen Infants | Pur Minerals

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Hyvee Inc

Ibuprofen Infants | Par Pharmaceutical Inc.

2.1 Adult Hypertension
Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with candesartan cilexetil.

Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].

Candesartan cilexetil may be administered with or without food.

If blood pressure is not controlled by candesartan cilexetil alone, a diuretic may be added. Candesartan cilexetil may be administered with other antihypertensive agents.
2.2 Pediatric Hypertension 1 to < 17 Years of age
Candesartan cilexetil may be administered once daily or divided into two equal doses. Adjust the dosage according to blood pressure response. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate candesartan cilexetil under close medical supervision and consider administration of a lower dose [see WARNINGS AND PRECAUTIONS (5.3)].

Children 1 to < 6 years of age:

The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension).

Children 6 to < 17 years of age:

For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg.

For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg.

Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients [see CLINICAL STUDIES (14.1)].

An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with candesartan cilexetil.

Children < 1 year of age must not receive candesartan cilexetil for hypertension.

All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive candesartan cilexetil since candesartan cilexetil has not been studied in this population [see SPECIAL POPULATIONS (8)].

For children who cannot swallow tablets, an oral suspension may be substituted as described below:

Preparation of Oral Suspension:

Candesartan cilexetil oral suspension can be prepared in concentrations within the range of 0.1 to 2.0 mg/mL. Typically, a concentration of 1 mg/mL will be suitable for the prescribed dose. Any strength of candesartan cilexetil tablets can be used in the preparation of the suspension.

Follow the steps below for preparation of the suspension. The number of tablets and volume of vehicle specified below will yield 160 mL of a 1 mg/mL suspension.
• Prepare the vehicle by adding equal volumes of *Ora-Plus ® (80 mL) and *Ora-Sweet SF ® (80 mL) or, alternatively, use * ,†Ora-Blend SF ® (160 mL). • Add a small amount of vehicle to the required number of candesartan cilexetil tablets (five 32 mg tablets) and grind into a smooth paste using a mortar and pestle. • Add the paste to a preparation vessel of suitable size. • Rinse the mortar and pestle clean using the vehicle and add this to the vessel. Repeat, if necessary. • Prepare the final volume by adding the remaining vehicle. • Mix thoroughly. • Dispense into suitably sized amber PET bottles. • Label with an expiry date of 100 days and include the following instructions: Store at room temperature (below 30°C/86°F). Use within 30 days after first opening. Do not use after the expiry date stated on the bottle. Do not freeze. Shake well before each use.
*Ora-Plus®, Ora-Sweet SF®, and Ora-Blend SF® are registered trademarks of Paddock Laboratories, Inc.

†Supplied as a 50/50% pre-mix of Ora-Plus® and Ora-Sweet SF®.
2.3 Adult Heart Failure
The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient.

No Recall
Walgreen Company

Ibuprofen Infants | Walgreen Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day
Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

No Recall
Kroger Company

Ibuprofen Infants | Kroger Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day
Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

No Recall
Meijer Distribution Inc

Ibuprofen Infants | Mckesson

• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day
Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

No Recall