Blog Maine: Advil Infants Concentrated Drops

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)*

*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

Infant’s 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

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	NDC Product Code (Source)	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

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	PURPLE (translucent purple)	Score
Shape		Size
Flavor	GRAPE (grape flavor with grape odor)	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0573-0193-20	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
1		15 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (0573-0193-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020812	06/19/1998