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See all Acetaminophen Extended Release brands

Acetaminophen Extended Release

Dosage form: tablet, film coated, extended release
Ingredients: ACETAMINOPHEN 650mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC code: 0615-7590

Medically reviewed by Drugs.com. Last updated on Nov 17, 2023.

Acetaminophen ER 650mg

Active ingredient (in each caplet)

Acetaminophen 650mg

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 for more than 10 days

    •    fever gets worse or lasts for 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 at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide.

Questions or comments?

1-800-719-9260

U.S. Patent 7,897,172

Gluten Free

Distributed by: MAJOR® PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48510 USA

M-05 REV. 10/14

Principal Display Panel

Acetaminophen Extended-Release Tablets 650 mg

ACETAMINOPHEN EXTENDED RELEASE 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7590(NDC:0904-5769)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
POVIDONE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size19mm
FlavorImprint CodeL544
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7590-3930 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507702/25/2000
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943REPACK(0615-7590)

 
NCS HealthCare of KY, Inc dba Vangard Labs

See all Acetaminophen Extended Release brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.