Acetaminophen
FDA Label NDC 21695-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Acetaminophen (NDC 21695-008). 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 active ingredient, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Keep Out Of Reach Of Children

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient

Acetaminophen 325mg

Acetaminophen 500mg

Keep Out Of Reach Of Children

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as children, even if you do not notice symptoms or signs.

Uses

Use for temporary relief of minor aches and pains due to:

° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever

Warnings

Alcohol Warning: If you consume 3 or more alcoholic beverages every day, ask your doctor whether you should take Acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use with any other product containing Acetaminophen or if you have ever had an allergic reaction to pain relievers/fever reducers.

Stop use and ask a doctor if

° new symptoms occur ° redness or swelling is present ° pain gets worse or lasts more than 10 days ° fever gets worse or lasts more than 3 days.

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

Directions

Do not take more than directed

° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.