Acetaminophen
FDA Label NDC 67510-0153

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Acetaminophen (NDC 67510-0153). 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 tablet), purpose, warnings, liver warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use 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 Ingredients (In Each Tablet)


Acetaminophen 500mg


Purpose

Pain Reliever/fever reducer

Warnings


Liver Warning:

this product contains acetaminophen.  Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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 Use If You Are

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

    • These could be sign of a serious condition

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children.

Enter section text here

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.  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 tablets every 4 to 6 house as needed
    • do not take more than 8 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor


    children under 12 years
    		do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • do not use if imprinted safety seal under cap is broken or missing.
  • Store at 15° - 30°C (59° - 86°F)
  • see end panel for lot number and expiration date

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • mentrual cramps
  • temporarily reduces fever

Package Label

Non-Aspirin Pain Relief Extra Strength 40 caplates

Image Of Carton Label (Nonasp40cap.6.carton)

Image Of Carton Label (Nonasp40cap.6.carton)

Non-Aspirin Pain Relief Extra Strength 40 tablets

Image Description (Nonasp40tab.6.carton)

Image Description (Nonasp40tab.6.carton)

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