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  5. Label Information: Apinophen Extra Strength

FDA Label for Apinophen Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNING
    6. DIRECTIONS
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Apinophen Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product A P J Laboratories Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Keep Out Of Reach Of Children



Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Uses





temporarily relieves minor aches and pains due to:

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


Warning



Liver warning:


This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product


Directions



do not take more than directed (see overdose warning)

adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last
swallow whole – do not crush, chew, or dissolve
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children under 12 years : ask a doctor


Inactive Ingredient



LACTOSE MONOHYDRATE

STARCH, CORN

GELATIN

METHYLPARABEN
PROPYLPARABEN
MAGNESIUM STEARATE
TALC
SODIUM STARCH GLYCOLATE TYPE A POTATO

SILICON DIOXIDE


Package Label.Principal Display Panel



product - mm1 apinophen

product - mm1 apinophen

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