INFANTS ADVIL IBUPROFEN HALEON US HOLDINGS LLC FDA Approved Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, headaches and toothaches

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 1.25 mL) Ibuprofen 50 mg (NSAID) nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients acetic acid artificial flavor butylated hydroxytoluene carboxymethylcellulose sodium citric acid monohydrate edetate disodium glycerin microcrystalline cellulose polysorbate 80 propylene glycol purified water sodium benzoate sorbitol solution sucrose xanthan gum
Strengths
1.25 ml 50 mg
Quantities
25 ml 15 ml
Treats Conditions
Uses Temporarily Reduces Fever Relieves Minor Aches And Pains Due To The Common Cold Flu Headaches And Toothaches
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL Infants' Advil ® Concentrated Drops Ibuprofen Oral Suspension 50 mg per 1.25 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Dye-Free White Grape Flavored Drops for ages 6–23 months 1/2 FL OZ (15 mL) Alcohol-Free Principal Display Panel - 15 mL Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Infants' Advil ® Concentrated Drops Ibuprofen Oral Suspension 50 mg per 1.25 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Dye-Free White Grape Flavored Drops for ages 6–23 months 1/2 FL OZ (15 mL) Alcohol-Free Principal Display Panel - 15 mL Bottle Carton

Overview

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

Indications & Usage

Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, 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 • 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 with the dosing device provided. Do not use with any other device. Dosing Chart Weight (lb) Age (mos) Dose (mL) under 6 mos ask a doctor 12-17 lb 6-11 mos 1.25 mL 18-23 lb 12-23 mos 1.875 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. 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 the body • slurred speech • leg swelling • 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 the body • slurred speech • leg swelling • 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.

Storage & Handling

Other Information • one dose lasts 6-8 hours • store at 20-25°C (68-77°F) • see bottom of box for lot number and expiration date

Questions

Questions or comments? Call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional For most recent product information, visit www.Advil.com.


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