Acetaminophen
FDA Label NDC 50090-2783

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Acetaminophen (NDC 50090-2783). 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 tablet)/purpose, uses, purpose, alcohol warning:, do not use, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)/Purpose

Acetaminophen 325mg....................Analgesic/Antipyretic

Uses

temporary relief of minor aches and pains associated with

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • and reduction of fever

Purpose

Analgesic/Antipyretic

Alcohol Warning:

If you consume 3 or more alcoholic drinks 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 products containing acetaminophen.

Stop Use And Ask A Doctor If

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

Dosage & Administration

Directions

Adults and children 12 years of age and older

  • take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

    • Children 6-11 years of age

    • Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.

      • Children under 6 years of age

      • Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Storage And Handling

Other Information

  • store at room temperature 59°-86°F (15°-30°C).

Inactive Ingredient

Inactive Ingredients corn starch, pregelatinized starch, stearic acid.

May contain povidone and sodium starch glycolates.

How Supplied

Product: 50090-2783

NDC: 50090-2783-0 1 TABLET in a BLISTER PACK / 30 in a BOX, UNIT-DOSE

NDC: 50090-2783-1 30 TABLET in a BLISTER PACK / 25 in a BOX, UNIT-DOSE

* Please review the disclaimer below.