Acetaminophen
FDA Label NDC 52204-115

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cispharma, Inc for the product Acetaminophen (NDC 52204-115). 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 drug facts, uses, warnings, overdose warning:, directions: do not take more than directed (see overdose warning), other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each caplet)

Acetaminophen .....................500 mg

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • the common cold
  • backache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps

    • temporarily reduces fever

Warnings

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

Overdose Warning:

Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact 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 caplets every 6 hours as needed.
  • do not take more than 8 caplets in 24 hours
  • do not use more than 10 days unless directed by a doctor

children under 12 years

  • do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

  • store between 20°- 25°C (68°- 77°F)
  • do not use if the box is opened

Inactive Ingredients

Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

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