APROFEN REGULAR STRENGTH- ibuprofen tablet

APROFEN by

Drug Labeling and Warnings

APROFEN by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ibuprofen USP, 200 mg (NSAID)

PURPOSE

Pain reliever/fever reducer

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

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

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 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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

INACTIVE INGREDIENT

STARCH, CORN

INACTIVE INGREDIENT

GELATIN

INACTIVE INGREDIENT

METHYLPARABEN

INACTIVE INGREDIENT

TITANIUM DIOXIDE

INACTIVE INGREDIENT

MAGNESIUM STEARATE

INACTIVE INGREDIENT

TALC

INACTIVE INGREDIENT

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT

SILICON DIOXIDE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APROFEN  REGULAR STRENGTH
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-021
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)	40 mg
STARCH, CORN (UNII: O8232NY3SJ)	20 mg
GELATIN (UNII: 2G86QN327L)	2 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	3 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.1 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	10 mg
TALC (UNII: 7SEV7J4R1U)	10 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	20 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	1 mg

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	200mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-021-26	500 in 1 BLISTER PACK
2	NDC: 46084-021-24	250 in 1 BLISTER PACK
3	NDC: 46084-021-23	100 in 1 BLISTER PACK
4	NDC: 46084-021-22	50 in 1 BLISTER PACK
5	NDC: 46084-021-31	2 in 1 BLISTER PACK

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	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-021)