Acetaminophen Tablet, Extended Release
FDA Label NDC 21130-108

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Acetaminophen (NDC 21130-108). 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 drug facts, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 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 tablets 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 tablets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 tablets 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 at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
  • do not use if carton is opened or foil inner seal is broken
  • USP Dissolution test is pending 

Inactive Ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments? 
 call 1-855-274-4122

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASONTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com

MADE IN INDIA

CODE: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 650 Mg (225 Tablets Bottle)

TO OPEN:
1. PUSH DOWN
2. TURN CAP

Signaturte
Care®                            
Quality
Guaranteed

DO NOT USE
WITH OTHER
MEDICINES
CONTAINING
ACETAMINOPHEN

8 HOUR                                
NDC 21130-108-35
ARTHRITIS
PAIN
RELIEVER

ACETAMINOPHEN

Extended-Release Tablets USP, 650 mg
Pain Reliever/Fever Reducer

For the temporary relief of                 225
minor arthritis pain                  Extended-Release
                                                     Tablets
      

Package Label-principal Display Panel (650 mg (24 Tablets Bottle))

Package Label-principal Display Panel (650 mg (24 Tablets Bottle))

    

Package Label-Principal Display Panel - 650 Mg (225 Tablets Container Carton)

Compare to Tylenol®8HR Arthritis Pain
active ingredient*

NDC 21130-108-35

Signature
Care®

Quality Guaranteed

DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN


8 HOUR

ARTHRITIS
PAIN 
RELIEVER
ACETAMINOPHEN
                        Actual Size
Extended-Release                                06
Tablets USP, 650 mg
Pain Reliever/Fever Reducer

For the temporary relief                225
of minor arthritis pain       Extended-release
                                               tablets
 


Package Label-principal Display Panel (650 mg (24 Tablets Container Carton))

Package Label-principal Display Panel (650 mg (24 Tablets Container Carton))







* Please review the disclaimer below.