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Principal Display Panel
SPL v4
SPL
SPL Set ID 19f8a11e-593a-49c1-b2f4-b147cbcfe97c
Route
ORAL
Published
Effective Date 2024-07-11
Document Type 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)

Drug Facts


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