ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet, film coated, extended release

Acetaminophen Extended Release by

Drug Labeling and Warnings

Acetaminophen Extended Release by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN EXTENDED RELEASE 
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-7590(NDC:0904-5769)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-7590-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/07/2010

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	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	REPACK(0615-7590)