APROFEN REGULAR STRENGTH: Package Insert and Label Information

APROFEN REGULAR STRENGTH- ibuprofen tablet
A P J Laboratories Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

product
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APROFEN REGULAR STRENGTH ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 40 mg
STARCH, CORN 20 mg
GELATIN 2 mg
METHYLPARABEN 3 mg
TITANIUM DIOXIDE 0.1 mg
MAGNESIUM STEARATE 10 mg
TALC 10 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO 20 mg
SILICON DIOXIDE 1 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 200mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46084-021-26 500 TABLET (TABLET) in 1 BLISTER PACK None
2 NDC:46084-021-24 250 TABLET (TABLET) in 1 BLISTER PACK None
3 NDC:46084-021-23 100 TABLET (TABLET) in 1 BLISTER PACK None
4 NDC:46084-021-22 50 TABLET (TABLET) in 1 BLISTER PACK None
5 NDC:46084-021-31 2 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 02/21/2013
Labeler — A P J Laboratories Limited (677378339)
Registrant — A P J Laboratories Limited (677378339)
Establishment
Name Address ID/FEI Operations
A P J Laboratories Limited 677378339 manufacture (46084-021)

Revised: 02/2013 A P J Laboratories Limited

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