Acetaminophen
FDA Label NDC 49483-252

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Acetaminophen (NDC 49483-252). 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 - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each tablet)Acetaminophen 500 mg

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Warnings

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you have:
  • more than 8 tablets 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

Otc - Do Not Use

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor

Ask a doctor before use if you have
  • liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

Otc - Stop Use

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
    • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions
  • do not take more than directed (see overdose warning)
    • adults and children 12 years and over
    • take 2 tablets (1,000 mg) every 6 hours while symptoms last
    • do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
      • children under 12 years
      • do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Storage And Handling

Other information
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredient

Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid*may contain this ingredient

Package Label.Principal Display Panel

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* Please review the disclaimer below.