Label: CHILDRENS ADVIL- ibuprofen suspension
- NDC Code(s): 0573-1174-12
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Allergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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
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- has had stomach ulcers or bleeding problems
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- takes a blood thinning (anticoagulant) or steroid drug
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- takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- 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
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- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- stomach bleeding warning applies to the child
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- child has problems or serious side effects from taking pain relievers or fever reducers
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- child has a history of stomach problems, such as heartburn
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- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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- child has not been drinking fluids
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- child has lost a lot of fluid due to vomiting or diarrhea
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- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
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- under a doctor's care for any serious condition
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- taking any other drug
Stop use and ask a doctor if
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- child experiences any of the following signs of stomach bleeding:
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- feels faint
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- vomits blood
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- has bloody or black stools
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- has stomach pain that does not get better
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- child has symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- the child does not get any relief within first day (24 hours) of treatment
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- fever or pain gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- shake well before using
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- mL = milliliter
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- find right dose on chart below. If possible, use weight to dose; otherwise use age.
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- repeat dose every 6-8 hours, if needed
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- do not use more than 4 times a day
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- 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
- Other information
- Inactive ingredients
- Questions or comments?
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Additional Information
Long Lasting: Up to 8 hours of fever reduction
Great Convenience: Long duration means fewer doses needed per day.
Alcohol-Free
For most recent production information,
Visit www.Advil.com
Pfizer, Madison, NJ 07940 USA © 2019 Pfizer Inc.
Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 2 years – 11 years.
Packaged with Tamper-Evident bottle cap.
Do Not Use if breakable ring is separated or missing.
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PRINCIPAL DISPLAY PANEL
NDC0573-1174-12
Children's
Advil®
SuspensionIbuprofen Oral Suspension
100 mg per 5 mL
Pain Reliever/Fever Reducer (NSAID)Fever
Aches & Pains
Lasts Up To
8
HoursSame Great Flavor!
Now Dye-FreeDye-Free
BLUE RASPBERRY
Blue Raspberry-Flavored Liquid
for ages 2-11 years4 FL OZ (120 mL)
Alcohol-FreePAA105480 Front Carton
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INGREDIENTS AND APPEARANCE
CHILDRENS ADVIL
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-1174 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (Translucent) Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-1174-12 1 in 1 CARTON 09/30/2019 1 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020589 06/27/1996 Labeler - Haleon US Holdings LLC (079944263)
