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Major Childrens Ibuprofen

Pronunciation

Generic Name: ibuprofen
Dosage Form: suspension

Major Pharmaceuticals Children's Ibuprofen Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Slideshow: Is it Safe to Give Human Medicine to Pets?

Always get your pet's drug and dose recommendation from the veterinarian.

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

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 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
  • 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

  • give with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

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.
  • use only with enclosed measuring cup
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
  • wash dosage cup after each use
Dosing Chart
Weight (lb) Age(yrs) Dose (teaspoonful or mL)
under 2 years ask a doctor
24-35 lbs 2-3 years 1 tsp or 5 mL
36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL
48-59 lbs 6-8 years 2 tsp or 10 mL
60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL
72-95 lbs 11 years 3 tsp or 15 mL

Other information

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

Inactive ingredients

anhydrous citric acid, butylparaben, corn syrup, D&C red #33, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

For Ages 2 to 11

Children’s

Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Lasts Up to 8 Hours

Berry Flavored Liquid

Alcohol Free

Children's

Compare to the active ingredient of Children’s Motrin®

Children's Ibuprofen Carton

Major Childrens Ibuprofen 
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5309
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg  in 5 mL
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor BERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0904-5309-09 1 BOTTLE (BOTTLE) in 1 CARTON
1 240 mL in 1 BOTTLE
2 NDC:0904-5309-20 1 BOTTLE (BOTTLE) in 1 CARTON
2 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074937 02/01/2000
Labeler - Major Pharmaceuticals (191427277)
Revised: 11/2009
 
Major Pharmaceuticals



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