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 325mg

Purposes

Pain reliever/fever reducer

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

                 adult takes more than 12 tablets in 24 hours, which is the maximum daily amount

                 child takes more than 5 doses in 24 hours

                 taken with other drugs containing acetaminophen

                 adult has 3 or more alcoholic drinks every day while using this product

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 the user

has liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

Pain gets worse or lasts more than 10 days in adults and children

 Pain gets worse or lasts more than 5 days in children under 12 years

 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:

Taking more than 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

• AGE: DOSE
• Adults and children 12 years and over:
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
• Children 6 to 11 years:
  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours
• Children under 6 years: Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

• Do no use if imprinted Safety Seal under cap is broken or missing.
• Store at room temperature.

Inactive ingredients

Povidone, Pregelantized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

Adverse Drug Event call (800) 616-2471

Dist. By MAJOR PHARMACEUTICALS,

31778 Enterprise Drive,

Livonia, MI 48150 USA

Rev. 09/10  M-95

Principal Display Panel

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-0591(NDC:0904-1982)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K12 (UNII: 333AG72FWJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (round flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPI;A325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-0591-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/03/2011	02/28/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/21/2011	02/28/2021

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(0615-0591)