Acetaminophen Caplets, 500 Mg
FDA Label NDC 70795-1200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Graxcell Pharmaceutical, Llc for the product Acetaminophen Caplets, 500 Mg (NDC 70795-1200). 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 physician before use, stop use and ask a physician, if pregnant or breast-feeding, 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 of 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 you take

  • more than 4,000 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.
      • you have ever had an allergic reaction to this productor any of its ingredients

        • 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.

Do Not Use

without consulting a physician

Ask A Physician Before Use

 if you have a sodium restricted diet due to multiple organ diseases

Stop Use And Ask A Physician

If symptoms of heat cramps continue for more than 24 hours

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away

Otc - Keep Out Of Reach Of Children

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

  • do not take more than directed (see overdose warning)

    • Adults and children 12 years and over

    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

      • Children under 12 years

      • ask a doctor

Other Information

  • Store at room temperature 20°-25°C (68°-77°F).

Inactive Ingredients

carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

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