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ACETAMINOPHEN by HIMPRIT PHARMACHEM PVT LTD

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: HIMPRIT PHARMACHEM PVT LTD
NDC Code: 65437-040

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACETAINOPHEN TABLETS USP 500 mg

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"

ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-040
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM METABISULFITE 
SILICON DIOXIDE 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
POLYETHYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeS;500
Contains    
Packaging
#Item CodePackage Description
1NDC:65437-040-311 BAG (BAG) in 1 DRUM
131000 TABLET, FILM COATED (TABLET) in 1 BAG
2NDC:65437-040-501 BAG (BAG) in 1 DRUM
250000 TABLET, FILM COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34307/01/2010
Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)

 
HIMPRIT PHARMACHEM PVT LTD

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Medically reviewed on Jul 20, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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