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Topcare Ibuprofen Drops

Pronunciation

Generic Name: ibuprofen
Dosage Form: oral suspension

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Topco Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, sore throat, 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

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

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 stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
child has asthma
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

give 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
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. (1-800-222-1222)

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.
measure with the dosing device provided. Do not use with any other device.
dispense liquid slowly into the child’s mouth, toward the inner cheek
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

Dosing Chart
Weight (lb)	Age (mos)	Dose (mL)
under 6 mos		ask a doctor
12-17 lbs	6-11 mos	1.25 mL
18-23 lbs	12-23 mos	1.875 mL

Other information

do not use if printed neckband is broken or missing
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-888-423-0139

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See New Warnings Information

For Ages 6 Mos. to 23 Mos.

Concentrated Drops

Infants’

Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Non-Staining

Alcohol Free

Dye-Free

Berry Flavor

Use Only with Enclosed Syringe

Compare to Motrin® Infants’ Drops Dye-Free active ingredient

Ibuprofen Oral Suspension Carton

TOPCARE IBUPROFEN
ibuprofen suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-255
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 (Opaque)	Score
Shape		Size
Flavor	BERRY (mixed)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:36800-255-10	1 BOTTLE (BOTTLE) in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075217	09/10/2004

Labeler - Topco Associates LLC (006935977)

Revised: 06/2009

Topco Associates LLC

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