Acetaminophen by NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen 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 (in each tablet)

Acetaminophen 500 mg

Purposes

Pain Reliever/Fever Reducer

Aspirin Free Extra Strength Pain Reliever

Uses

for the temporary relief of minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• 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 more than 10 days
• fever gets worse or lasts 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 and children 12 years and over:

• take 2 tablets every 6 hours while symptoms last.
• do not take more than 6 tablets in 24 hours unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information

• Store at room temperature

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call (800) 616-2471

Distributed By: MAJOR® PHARMACEUTICALS,

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

Rev. 11/16 M-95

Principal Display Panel

 

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-4510(NDC:0904-1988)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND (round flat faced beveled edge)	Size	12mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-4510-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/04/2011	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/04/2011	05/31/2020

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(0615-4510)