Acetaminophen Extended-release Tablets, 650 Mg Tablet, Extended Release
FDA Label NDC 25000-071

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Acetaminophen Extended-release Tablets, 650 Mg (NDC 25000-071). 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 caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, 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 Caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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 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

  • 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.

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children.

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
    • take 2 caplets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 caplets in 24 hours
    • do not use for more than 10 days unless directed by a doctor 
     Under 18 years of age 
    • ask a doctor

    Other information

    • store between 20-25°C (68-77°F)
    • The FDA approved Dissolution methods differ from USP
    • do not use if carton is opened. Do not use if foil inner seal is broken or missing

Inactive Ingredients

carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments ?
Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST

Principal Display Panel

NDC 25000-071-02
Acetaminophen Extended-Release Tablets USP, 650 mg
24 count carton label


Aceta-24s-carton (Aceta 24s Carton)

Aceta-24s-carton (Aceta 24s Carton)



NDC 25000-071-02
Acetaminophen Extended-Release Tablets USP, 650 mg
24 count bottle label


Aceta-24s-label (Aceta 24s Label)

Aceta-24s-label (Aceta 24s Label)



NDC 25000-071-08
Acetaminophen Extended-Release Tablets USP, 650 mg
100 count carton label


Aceta-100s-carton (Aceta 100s Carton)

Aceta-100s-carton (Aceta 100s Carton)



NDC 25000-071-08
Acetaminophen Extended-Release Tablets USP, 650 mg
100 count bottle label


Aceta-100s-label (Aceta 100s Label)

Aceta-100s-label (Aceta 100s Label)



NDC 25000-071-10
Acetaminophen Extended-Release Tablets USP, 650 mg
225 count carton label


Aceta-225s-carton (Aceta 225s Carton)

Aceta-225s-carton (Aceta 225s Carton)


NDC 25000-071-10
Acetaminophen Extended-Release Tablets USP, 650 mg
225 count bottle label


Aceta-225s-label (Aceta 225s Label)

Aceta-225s-label (Aceta 225s Label)



NDC 25000-071-11
Acetaminophen Extended-Release Tablets USP, 650 mg
290 count carton label


 

Aceta-290s-carton (Aceta 290s Carton)

Aceta-290s-carton (Aceta 290s Carton)


NDC 25000-071-11
Acetaminophen Extended-Release Tablets USP, 650 mg
290 count bottle label


 

Aceta-290s-label (Aceta 290s Label)

Aceta-290s-label (Aceta 290s Label)



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