Pain Reliever Tablet, Film Coated
FDA Label NDC 71679-304

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 Pain Reliever (NDC 71679-304). 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 you have, ask a doctor or pharmacist before use if you are, 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 500 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 
  • temporarily reduces fever
  • premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3000 mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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 You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than 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.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over:
  • take 2 caplets every 6 hours while symptoms last
  • do not take mote than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
  • children under 12 years of age: do not use

Other Information

  • store at 15° to 30°C (59° to 86°F)
  • read all product information before using

Inactive Ingredients

Pregelatinized Starch, Povidone, Stearic Acid powder, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose, Polyethylene Glycol, Titanium Dioxide, Talc

Questions Or Comments?

Call +1-844-832-1138 Mon - Fri 9 AM - 5 PM EST

Package Label.Principal Display Panel

Label (Label)

Label (Label)

* Please review the disclaimer below.