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19f8a11e-593a-49c1-b2f4-b147cbcfe97c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
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.
Indications and Usage
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Dosage and Administration
this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor
Description
Drug Facts
Section 44425-7
each 5 mL contains: sodium 2 mg store between 20º to 25ºC (68º to 77ºF) Children's Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms: NDC 63739-798-01:5 mL Unit Dose Cup NDC 63739-798-10: Case of 100, 5 mL Unit Dose Cups
Section 50565-1
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50566-9
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 child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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
Section 50567-7
take with food or milk if stomach upset occurs
Section 50568-5
under a doctor's care for any serious condition taking any other drug
Section 50569-3
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, kidney disease, or had a stroke child has asthma child is taking a diuretic
Section 50570-1
if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery
Section 51727-6
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.
Section 51945-4
Delivers 5 mL NDC63739-798-01 Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL
Section 53413-1
Call 1-800-845-8210. *All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Children's Motrin® Dye-Free Berry Flavor. Manufactured By: PAI Pharma Greenville, SC 29605 Distributed By: McKesson Corportion d/b/a SKY Packaging Memphis, TN 38141 ©2003 McKesson Corporation Iss. 12/2023
Section 55105-1
relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Section 55106-9
Drug Facts
Structured Label Content
Indications and Usage (34067-9)
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Dosage and Administration (34068-7)
this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor
Warnings and Precautions (34071-1)
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.
Section 44425-7 (44425-7)
each 5 mL contains: sodium 2 mg store between 20º to 25ºC (68º to 77ºF) Children's Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms: NDC 63739-798-01:5 mL Unit Dose Cup NDC 63739-798-10: Case of 100, 5 mL Unit Dose Cups
Section 50565-1 (50565-1)
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50566-9 (50566-9)
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 child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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
Section 50567-7 (50567-7)
take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)
under a doctor's care for any serious condition taking any other drug
Section 50569-3 (50569-3)
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, kidney disease, or had a stroke child has asthma child is taking a diuretic
Section 50570-1 (50570-1)
if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery
Section 51727-6 (51727-6)
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.
Section 51945-4 (51945-4)
Delivers 5 mL NDC63739-798-01 Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL
Section 53413-1 (53413-1)
Call 1-800-845-8210. *All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Children's Motrin® Dye-Free Berry Flavor. Manufactured By: PAI Pharma Greenville, SC 29605 Distributed By: McKesson Corportion d/b/a SKY Packaging Memphis, TN 38141 ©2003 McKesson Corporation Iss. 12/2023
Section 55105-1 (55105-1)
relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Section 55106-9 (55106-9)
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Source: dailymed · Ingested: 2026-02-15T12:05:40.770338 · Updated: 2026-02-15T12:05:40.727581