Acetaminophen
FDA Label NDC 71399-2855

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Acetaminophen (NDC 71399-2855). 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 doctor before use if the user has, stop use and ask a doctor if:, keep out of reach of children., 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

To reduce fever and for the temporary relief of 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 

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours 
  • taken with other drugs containing acetaminophen 
  • adult has 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If The User Has

  • has liver disease
  • is a child with pain of arthritis

Stop Use And Ask A Doctor If:

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

Keep Out Of Reach Of Children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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)

Do not take more then directed (see overdose warning)

adults & children 12 years and over
  •  take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 Children 6 to 11 years
  •  take one tablet every 4 to 6 hourswhile sysmtoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
 child under 6 years ask a doctor

Other Information

  • store at temperature 15° to 30°C (59° to 86°F)

Inactive Ingredients:

pregelatinized starch, microcrystalline cellulose, povidone, colloidal silicon dioxide, croscarmellose sodium, stearic acid

Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for
Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

*This product is not manufactured or distributed by McNeil Consumer Inc., distributor of Regular Strength Tylenol Tablets.

* Please review the disclaimer below.