Acetaminophen Tablet, Film Coated
FDA Label NDC 71679-305

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Acetaminophen (NDC 71679-305). 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:, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, 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 Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/Fever reducer

Uses:

  • temporarily relieves 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adults has 3 or more alcoholic drinks every day while using this product

    • Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash 

      • If a skin reaction occurs, stop use and seek medical help right away.

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.

Ask A Doctor Before Use If The User Has

liver disease

Ask A Doctor Or Pharmacist Before Use If The User Is

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If:

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take mote than 10 tablets in 24 hours, unless directed by doctor
  • do not use 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 doctor

Other Information

  • store between 20°-25°C (68°-77°F)
  • read all product information before using
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

Pregelatinized Starch, Polyvinyl Pyrrolidone, Microcrystalline Cellulose, Stearic acid powder,  Magnesium Stearate, Hypromellose-5 & 15, Polyethylene Glycol-400, Talc, Titanium Dioxide.

Questions Or Comments?

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