ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet, film coated, extended release
NCS HealthCare of KY, LLC dba Vangard Labs

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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

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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	OVAL	Size	19mm
Flavor		Imprint Code	L544
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-7590-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/07/2010	06/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075077	02/25/2000	06/30/2023

Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-7590)

Revised: 11/2019

Document Id: a7a59648-35e2-4114-9e0a-aa3ef4606397

Set id: 61c8503f-96d7-483b-8832-3494d9cf07c6

Version: 17

Effective Time: 20191127

NCS HealthCare of KY, LLC dba Vangard Labs