APROFEN description, usages, side effects, indications, overdosage, supplying and lots more!

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APROFEN

A P J Laboratories Limited
A P J Laboratories Limited




FULL PRESCRIBING INFORMATION

Active ingredient

Purpose

Pain reliever/fever reducer



Uses

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









APROFEN

APROFEN

IBUPROFEN TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:46084-021
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
STARCH, CORN
GELATIN
METHYLPARABEN
titanium dioxide
MAGNESIUM STEARATE
talc
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
white 10 mm 200mg ROUND

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
part part343 2013-02-21


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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