Acetaminophen
FDA Label NDC 61010-4406

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Acetaminophen (NDC 61010-4406). 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 ingredients (in each caplet), purpose, uses, other, do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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 Ingredients (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Other

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 case 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

Otc - Ask Doctor

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

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 last 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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 the product at controlled room temperature 15°-30°C (59°-86°F).
  • Protect from light, moisture and freezing.

Inactive Ingredients

hypromellose, polyethylene glycol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions Or Comments?

Call toll free: 1-800-456-7077

Principal Display Panel – Pouch Label

DO NOT USE IF POUCH IS TORN OR DAMAGED

Safetec
of America, Inc.

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Principal Display Panel – Pouch Label (Ace0o 0001 01)

Principal Display Panel – Pouch Label (Ace0o 0001 01)

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