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APROFEN REGULAR STRENGTH

Medically reviewed by Drugs.com. Last updated on Feb 11, 2021.

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: A P J Laboratories Limited
NDC Code: 46084-021

Ibuprofen USP, 200 mg (NSAID)

Pain reliever/fever reducer


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

temporarily relieves minor aches and pains due to:

headache
muscular aches
minor pain of arthritis
toothache
backache
the common cold
menstrual cramps
temporarily reduces fever


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 severe stomach bleeding. The chances are higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed


do not take more than directed

the smallest effective dose should be used

 
Adults and children 12 years and older: take 1 tablet every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 tablet, 2 tablets may be used

do not exceed 6 tablets in 24 hours, unless directed by a doctor
 
Children under 12 years: ask a doctor



CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

STARCH, CORN


GELATIN


METHYLPARABEN

TITANIUM DIOXIDE


MAGNESIUM STEARATE

TALC

SODIUM STARCH GLYCOLATE TYPE A POTATO


SILICON DIOXIDE

APROFEN  REGULAR STRENGTH
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-021
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS40 mg
STARCH, CORN20 mg
GELATIN2 mg
METHYLPARABEN3 mg
TITANIUM DIOXIDE0.1 mg
MAGNESIUM STEARATE10 mg
TALC10 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO20 mg
SILICON DIOXIDE1 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code200mg
Contains    
Packaging
#Item CodePackage Description
1NDC:46084-021-26500 TABLET (TABLET) in 1 BLISTER PACK
2NDC:46084-021-24250 TABLET (TABLET) in 1 BLISTER PACK
3NDC:46084-021-23100 TABLET (TABLET) in 1 BLISTER PACK
4NDC:46084-021-2250 TABLET (TABLET) in 1 BLISTER PACK
5NDC:46084-021-312 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/21/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIOperations
A P J Laboratories Limited677378339manufacture(46084-021)

 
A P J Laboratories Limited

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.