Major Childrens Ibuprofen

Name: Major Childrens Ibuprofen

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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

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

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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