CHILDRENS ADVIL IBUPROFEN HALEON US HOLDINGS LLC FDA Approved Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
NDA020589
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients artificial and natural flavors carboxymethylcellulose sodium citric acid monohydrate edetate disodium glycerin microcrystalline cellulose polysorbate 80 propylene glycol purified water sodium benzoate sodium citrate sorbitol solution sucrose xanthan gum
Strengths
5 ml 100 mg
Quantities
5 ml 120 ml
Treats Conditions
Uses Temporarily Reduces Fever Relieves Minor Aches And Pains Due To The Common Cold Flu Sore Throat Headaches And Toothaches
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL NDC 0573-1174-12 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Same Great Flavor! Now Dye-Free Dye-Free BLUE RASPBERRY Blue Raspberry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free PAA105480 Front Carton Children's Advil Suspension BR Dye-Free 4 FL oz (120 mL)

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 0573-1174-12 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Same Great Flavor! Now Dye-Free Dye-Free BLUE RASPBERRY Blue Raspberry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free PAA105480 Front Carton Children's Advil Suspension BR Dye-Free 4 FL oz (120 mL)

Overview

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

Indications & Usage

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

Dosage & Administration

Directions • 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 below. If possible, use weight to dose; otherwise use age. • repeat dose every 6-8 hours , if needed • do not use more than 4 times a day • measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension. Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 5 mL 36-47 lb 4-5 yr 7.5 mL 48-59 lb 6-8 yr 10 mL 60-71 lb 9-10 yr 12.5 mL 72-95 lb 11 yr 15 mL

Warnings & Precautions
Warnings 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 the 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 Heart attack and stroke warning: 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. 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 the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • 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 • take with food or milk if stomach upset occurs 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 • 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Fever reducer/Pain reliever

Do Not Use

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

When Using

When using this product • take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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 • 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

Keep Out of Reach of Children

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

Questions

Questions or comments? call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional


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