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  5. Label Information: Pain Free Plus

FDA Label for Pain Free Plus

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Free Plus Product Label

The following document was submitted to the FDA by the labeler of this product Afassco Inc.. 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.

Otc - Active Ingredient



Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg


Otc - Purpose



Pin reliever, Stimulant


Indications & Usage



Uses: For the temporary relief of pain from:

• headaches • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • colds


Warnings



WARNING:

Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours

• with other drugs containing acetaminophen (prescription or non-prescription)

• 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug

• are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Dosage & Administration



DIRECTIONS:

Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.

Children under 12 years of age: Consult a doctor.


Inactive Ingredient



SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION


Package Label.Principal Display Panel



Afassco pain free plus - Afassco painfreeplus

Afassco pain free plus - Afassco painfreeplus


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