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

----------

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 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 
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
ColorWHITEScoreno score
ShapeOVAL (Oblong) Size19mm
FlavorImprint Code L544
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7590-3930 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/FEIBusiness Operations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL, REPACK

Revised: 12/2010
Document Id: da95681e-3667-415d-befb-d79061222015
Set id: 61c8503f-96d7-483b-8832-3494d9cf07c6
Version: 4
Effective Time: 20101215
 
NCS HealthCare of KY, Inc dba Vangard Labs