Label: INFANTS ADVIL- ibuprofen suspension/ drops
- NDC Code(s): 0573-0191-20, 0573-0191-22, 0573-0191-50, 0573-0191-75
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 20, 2023
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 1.25 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.
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 the body
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- slurred speech
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- leg swelling
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- 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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- 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 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
- Other Information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
INFANTS ADVIL
ibuprofen suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0191 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 50 mg in 1.25 mL Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (Translucent off-white) Score Shape Size Flavor GRAPE (White grape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0191-20 1 in 1 CARTON 01/30/1998 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0573-0191-50 1 in 1 CARTON 01/30/1998 2 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0573-0191-22 1 in 1 CARTON 01/30/2014 3 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 4 NDC:0573-0191-75 1 in 1 CARTON 01/30/1998 4 22.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020812 01/30/1998 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0573-0191) , LABEL(0573-0191) , MANUFACTURE(0573-0191) , PACK(0573-0191)
