Medication Guide App

Acetaminophen Extended Release

Dosage form: tablet
Ingredients: ACETAMINOPHEN 650mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7590

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

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

Gluten Free

Distributed by: MAJOR® PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48510 USA

M-05 REV. 09/12

Principal Display Panel

Acetaminophen Extended-Release Tablets 650mg

ACETAMINOPHEN EXTENDED RELEASE 
acetaminophen tablet
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 GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size19mm
FlavorImprint CodeL544
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7590-3930 TABLET (30 TABLET) 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 Labs050052943RELABEL(0615-7590), REPACK(0615-7590)

Revised: 08/2013
 
NCS HealthCare of KY, Inc dba Vangard Labs

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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