Acetaminophen Tablet
FDA Label NDC 84269-2522

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Acetaminophen (NDC 84269-2522). 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:, other, do not use:, ask a doctor before use if you have:, ask a doctor or pharmacist before us 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

Purpose

Pain reliever / fever reducer

Uses:

For the temporary relief of minor aches and pains associated with:

  • headache
  • toothache
  • muscular aches
  • common cold
  • minor arthritis pain
  • menstrual cramps
  • For the reduction of 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 cause skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.

      Children under 12 years: Ask a doctor

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 Us 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.

Otc - Pregnancy Or Breast Feeding

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

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Do not use more than directed

Adults And Children 12 Years And Over

  • take 2 tablets every 6 hours while symptoms persist or as directed by a doctor.
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

Other Information:

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

Corn starch, unspecified povidone, sodium starch glycolate, stearic acid

Principal Display Panel – 250 Tablet Box Label

2522

Maximum Strength Pain Reliever

ASPIRIN FREE

COMPARE TO
TYLENOL

For Temporary
Relief of Minor
Aches and Pains

250 tablets

2 Per Packet

The Provision
First Aid
Line™

BY WILDMAN

Principal Display Panel – 250 Tablet Box Label (Ace0z 0000 01)

Principal Display Panel – 250 Tablet Box Label (Ace0z 0000 01)

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