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Name:Acetaminophen Extended Release
Manufacturer:Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen ER 650mg

ACETAMINOPHEN EXTENDED RELEASE - acetaminophen tablet 
NCS HealthCare of KY, Inc dba Vangard Labs

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Acetaminophen ER 650mg

Active ingredient(s)

Active Ingredients (In each caplet)

Acetaminophen 650mg

Purpose

Pain Reliever

Use(s)

Temporarily relieves minor aches and pains due to: arthritis, muscular aches, the common cold, backache, headache, menstrual cramps, toothache ans 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.

For external use only

Do not use

If you are allergic to acetaminophen, with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

You have liver disease. If you are pregnant or breast-feeding.

Ask a doctor or pharmacist before use if

You are taking the blood thinning drug warfarin.

When using this product

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.

Pregnancy/Breastfeeding

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children.

Overdosage Section

Overdose Warning: Taking more then the recommended dose (overdose) may cause liver damage. 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 or dissolve, do not take more than 6 caplets in 24 hours, do not use for more than 10 days unless direected by a doctor.

Under 18 years of age: ask a doctor.

Other information

Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, USA

Storage

Store at 20 degrees - 25 degrees Celsus (68 degrees - 77 degrees Faranheit)

Avoid excessive heat 40 degrees Celsus (104 defrees Faranheit)

Inactive ingredients

Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose,magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide.

Questions

Questions or comments  1-800-719-9260

Principal Display Panel

Acetaminophen Extended-Release Tablets 650mg

Principal Display Panel-Acetaminophen ER 650mg Tablets

ACETAMINOPHEN EXTENDED RELEASE 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-7590(NDC:0904-5769)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
POVIDONE  
STARCH, PREGELATINIZED CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL (Oblong) Size 19mm
Flavor Imprint Code L544
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7590-39 30 TABLET (30 TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 02/25/2000

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL, REPACK

Revised: 12/2010 NCS HealthCare of KY, Inc dba Vangard Labs



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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