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Topcare Infants Ibuprofen


Generic Name: ibuprofen
Dosage Form: oral suspension

Topco Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?


Pain reliever/fever reducer



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


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)


  • 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, FD&C red #40, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?


Principal Display Panel

See New Warnings Information

For Ages 6 Mos. to 23 Mos.

Concentrated Drops


Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Alcohol Free

Berry Flavor

Use Only with Enclosed Syringe

Compare to Motrin® Infants’ Drops active ingredient

Ibuprofen Oral Suspension Carton

Topcare Infants Ibuprofen 
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-057
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Product Characteristics
Color PINK (light) Score     
Shape Size
Flavor FRUIT (mixed) Imprint Code
# Item Code Package Description
1 NDC:36800-057-05 1 BOTTLE (BOTTLE) in 1 CARTON
1 15 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075217 01/22/2002
Labeler - Topco Associates LLC (006935977)
Revised: 05/2009
Topco Associates LLC