Advil Infants Concentrated Drops

Generic Name: ibuprofen
Dosage Form: suspension, drops

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)*

Slideshow: Prescription Drug Addiction: Top 18 Facts for You and Your Family

*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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 the child has

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • not been drinking fluids
  • lost a lot of fluid due to vomiting or diarrhea
  • high blood pressure
  • heart or kidney disease
  • asthma
  • taken a diuretic

Ask a doctor or pharmacist before use if the child is

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • 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

  • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • 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.

DIRECTIONS

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • do not give longer than 10 days, unless directed by a doctor (see WARNINGS)
  • 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

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

Infant’s Advil Concentrated Drops White Grape (dye-free)

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

Infants Advil Concentrated Drops Grape

acetic acid, artificial flavors, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, FD&C red no. 40, 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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

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

1/2 FL OZ (15 mL)

Alcohol Free

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 6 months - 23 months.

For most recent product information, visit www.Advil.com.

Rinse the oral syringe with tap water only

Wyeth

Wyeth Consumer Healthcare Madison, NJ 07940 USA © 2009 Wyeth

Do Not Use if breakable ring on bottle cap is separated or missing.

Child-Resistant Safety Cap

INFANTS ADVIL CONCENTRATED DROPS 
ibuprofen suspension/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0193
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 50 mg  in 1.25 mL
Product Characteristics
Color PURPLE (translucent purple) Score     
Shape Size
Flavor GRAPE (grape flavor with grape odor) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0573-0193-20 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020812 06/19/1998
INFANTS ADVIL CONCENTRATED DROPS 
ibuprofen suspension/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0191
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 50 mg  in 1.25 mL
Product Characteristics
Color WHITE (Translucent off-white) Score     
Shape Size
Flavor GRAPE (White grape) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0573-0191-20 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020812 01/30/1998
Labeler - Wyeth Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Richmond Division of Wyeth 829390827 MANUFACTURE, ANALYSIS
Revised: 03/2010
 
Wyeth Consumer Healthcare



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