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, and toothache.

Warnings

For external use only

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if

You consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relivers/fever reducers.

Acetaminophen may cause liver damage.

When using this product

Stop use and ask a doctor if

New symptoms occir, redness or swelling is present, pain gets worse or lasts for more than 10 days.

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. 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 6 hours with water, swallow whole - do not crushm 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 19 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, pvidone, pregelatinized starch, stearic acid, titanium dioxide.

Questions

Questions or comments  1-800-719-9260

Principal Display Panel

Acetaminophen Extended-Release Tablets 650mg

ACETAMINOPHEN EXTENDED RELEASE  acetaminophen   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0615-7590 (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 No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape OVAL (Oblong) Size 19mm Flavor Imprint Code L544 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0615-7590-39 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: 09/2010NCS HealthCare of KY, Inc dba Vangard Labs