Aspirin 325mg
FDA Label NDC 51532-0232

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Aspirin 325mg (NDC 51532-0232). 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, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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