Acetaminophen Regular Strength Tablet
FDA Label NDC 54257-720

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magno-humphries, Inc. for the product Acetaminophen Regular Strength (NDC 54257-720). 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 (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains associated with:
  • headache
  • muscular aches 
  • backache
  • arthritis
  • common cold
  • toothache
  • menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount 
  • with other drugs containing acetaminophen 
  • 3 or more alcoholic drinks every day while using this product

Do Not Use

  • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

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. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 tablets every 4 to 6 hours as needed
  • do not take more than 4 tablets in 24 hours
  • do not take for more than 5 days unless directed by a doctor
children under 6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other Information

  • store at room temperature. Protect from moisture. 
  • avoid excessive heat 40°C (above 104° F)

Inactive Ingredients

Corn starch, pregelatinized starch, stearic acid, may contain povidone, sodium starch glycolate

Questions?

call toll-free 1-800-935-6737

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