Extra Strenghth Acetaminophen
FDA Label NDC 69729-107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Extra Strenghth Acetaminophen (NDC 69729-107). 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, purpose, uses, warnings, if pregnant or breast-feeding, keep out of reach of children., directions, other information, 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 500mg

Purpose

Pain reliever/fever reducer

Uses

  • temporary relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps and
  • 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.
      • if you have ever had an allergic reaction to this product or 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

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the reccomended 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.
Do not exceed recommended dosage.

Directions

  •  do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older:
  • 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 more than 10 days unless directed by a doctor.
  • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

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

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