Acetaminophen Tablet
FDA Label NDC 17714-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Acetaminophen (NDC 17714-012). 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, keep out of reach of children., directions, other information, inactive ingredients, 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 reduces fever and relieves minor aches and pains caused by

  • common cold
  • headache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 tablets in 24 hours, which is the maximum daily amount
  • 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 non prescription).        If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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

    • adult’s pain gets worse or lasts more than 10 days
    • child’s pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear

      • 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. Prompt 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 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 yearsask a doctor

Other Information

  • store at 15-30 °C (59-86 °F)

    • For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.

Inactive Ingredients

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Package Label.Principal Display Panel

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NDC: 17714-012-01 – 100 COUNT

NDC: 17714-012-10 – 1000 COUNT

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