Aprofen
FDA Label NDC 46084-021

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Aprofen (NDC 46084-021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Ibuprofen USP, 200 mg (NSAID)

Otc - Purpose

Pain reliever/fever reducer

Otc - 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
STARCH, CORN
GELATIN
METHYLPARABEN
TITANIUM DIOXIDE
MAGNESIUM STEARATE
TALC
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE

Package Label.Principal Display Panel

Product (Mm1 Aprophen)

Product (Mm1 Aprophen)

* Please review the disclaimer below.