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  5. Label Information: Aspirin 325mg

FDA Label for Aspirin 325mg

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. OTC - PREGNANCY OR BREAST FEEDING
    7. OVERDOSAGE
    8. DOSAGE & ADMINISTRATION
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 325mg 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



Aspirin USP (NSAID) 325 mg


Otc - Purpose



Pain Reliever


Indications & Usage



Uses:

For the relief of:

• headache • minor aches and pains

• for reduction of fever of colds and flu

• menstrual discomfort • toothache


Warnings



Warnings:

Reye’s Syndrome:

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.

Stomach Bleeding:

This product contains a nonsteroidal anti-inflammatory 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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Overdosage



In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions:

Do not use more than directed.

Adults and children 12 years of age and older: 1 to 2 tablets every 4 hours, do not exceed 12 tablets in 24 hours.

Children under 12 consult a physician.


Inactive Ingredient



SEE ORIGINAL BOX FOR COMPLETE

PRODUCT INFORMATION


Package Label.Principal Display Panel



affasco asa - Afassco aspirin

affasco asa - Afassco aspirin


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