INFANTS ADVIL

Dosage form: suspension/ drops
Ingredients: IBUPROFEN 50mg in 1.25mL
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-0191

INFANT'S ADVIL CONCENTRATED DROPS
INFANT'S ADVIL CONCENTRATED DROPS (Dye-Free)
(Ibuprofen)

Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)


nonsteroidal anti-inflammatory drug

Purpose

Fever reducer/Pain reliever

Uses

temporarily:

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

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

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, or asthma
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 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.

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 mosask a doctor
12-17 lb6-11 mos1.25 mL
18-23 lb12-23 mos1.875 mL

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

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

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.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Infants'
Advil
®
Concentrated Drops
Fever Reducer / Pain Reliever (NSAID)

White Grape-Flavored Drops
1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

New VALUE Size

Infants'
Advil
®
Concentrated Drops

Ibuprofen 50 mg Fever Reducer/
Pain Reliever (NSAID) per 1.25 mL

Fever

Aches & Pains

Lasts Up To
8
Hours

Dye-Free

White Grape Flavored Drops
for ages 6–23 months

1 FL OZ (30 mL)
Alcohol-Free

INFANTS ADVIL 
ibuprofen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0191
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
BUTYLATED HYDROXYTOLUENE 
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (Translucent off-white) Score    
ShapeSize
FlavorGRAPE (White grape) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0191-201 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
2NDC:0573-0191-501 BOTTLE, DROPPER in 1 CARTON
230 mL in 1 BOTTLE, DROPPER
3NDC:0573-0191-221 BOTTLE, DROPPER in 1 CARTON
315 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02081201/30/1998
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Pfizer Canada Inc.246770197ANALYSIS(0573-0191), LABEL(0573-0191), MANUFACTURE(0573-0191), PACK(0573-0191)

Revised: 09/2014
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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