ACETAMINOPHEN tablet, film coated

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by HIMPRIT PHARMACHEM PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

Temporarily relieves minor aches and pains due to :

• * headache * backache * the common cold * menstrual cramps:
  • * muscular aches
  • * arthritis
  • * toothache
  • * reduces fever

Warnings

Overdose Warning

Taking more than the recommended dose can cause serious health problems, including 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 you do not notice any signs or symptoms.

Alcohol Warnings

If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

• * with any other product containing acetaminophen

Stop use and Ask a doctor if

• * fever gets worse or lasts for more than 3 days
• * redness or swelling is present
• * pain gets worse or lasts for more than 10 days
• * new symptoms occur

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

Direction

• * do not use more that directed (see overdose warning)
• * adults and children 12 years and over : take 2 caplets every 6 hours as needed
• * do not take more than 8 caplets in 24 hours
• * Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

• * Store at room temperature

Inactive ingredients

croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Shipper Label

ACETAMINOPHEN TABLETS USP 500 mg
Each Film coated Tablet Contains:
ACETAMINOPHEN 500 MG

Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-040-31

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803

MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65437-040
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
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	S;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65437-040-31	1 in 1 DRUM
1		31000 in 1 BAG
2	NDC: 65437-040-50	1 in 1 DRUM
2		50000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	07/01/2010

Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)