Acetaminophen Tablet, Film Coated
FDA Label NDC 57237-346

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Acetaminophen (NDC 57237-346). 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 do not use if imprinted safety seal under cap is broken or missing.drug facts, uses, warnings, do not use, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing.Drug Facts

Active Ingredient (in each tablet)                          Purpose
Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer

Uses

To reduce fever and for the temporary relief of minor aches and
pains due to:

  • headache 
  • muscular aches
  • backache
  • minor pain from arthritis 
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 10 tablets in 24 hours, which is the maximum daily amount 
  • child takes more than 5 tablets in 24 hours 
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Directions

Do not take more than directed
Adults and Children 12 years and over:

  • take 2 tablets every 4 to 6 hours while symptoms last.
  • do not take more than 10 tablets in 24 hours.
  • do not take for more than 10 days unless directed by a doctor

    • Children 6 years to under 12 years:

    • take 1 tablet every 4 to 6 hours while symptoms last.
    • do not take more than 5 tablets in 24 hours.
    • do not use for more than 5 days unless directed by a doctor

      • Children under 6 years:
      ask a doctor

      Other Information

      • SODIUM FREE
      • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
      • see end panel for lot number and expiration date.

Inactive Ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

Package Label.Principal Display Panel

Acetaminophen

325 mg

100 Film Coated Tablets

Acetaminophen-325mg-label (Acetaminophen 325mg Label)

Acetaminophen-325mg-label (Acetaminophen 325mg Label)

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