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SENNA by HIMPRIT PHARMACHEM PVT LTD

Medically reviewed on November 13, 2017

Dosage form: tablet, film coated
Ingredients: SENNA 8.6mg
Labeler: HIMPRIT PHARMACHEM PVT LTD
NDC Code: 65437-087

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.

SENNA TABLETS 8.6 mg

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours

Warnings

Do not use
  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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

Keep out of reach of children. In case of overdose, get medial help or contact a Poison Control Center right away.

Directions
  • take preferably at bedtime or as directed by a doctor
agestarting dosagemaximum dosage
adults and children 12 years of age or older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information
  • each tablet contains: calcium 25mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

PRINCIPAL DISPLAY PANEL - Shipping Label

Each Film Coated Tablet Contains :
CALCIUM SENNOSIDES 8.6mg

Lot No. :
Mfg. Date :
Exp. Date :
Jar No. :
Quantity : 50,000 Tablets
NDC No : 65437 - 087 - 50

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59°-77°F (15°-25° 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 :
MANUFACTURER CODE No.: Guj/Drugs/G/1362
LABELER CODE # 14803

Manufactured For.
HIMPRIT PHARMACHEM PVT. LTD.
"LAKULESH", R.V. DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION,
BARODA, INDIA - 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

SENNA 
senna tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-087
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNA (SENNA) SENNA8.6 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
STEARIC ACID 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
HYPROMELLOSE 
MINERAL OIL 
WATER 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeS8
Contains    
Packaging
#Item CodePackage Description
1NDC:65437-087-501 BAG (BAG) in 1 DRUM
150000 TABLET, FILM COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33411/20/2009
Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
Registrant - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
NameAddressID/FEIOperations
ELYSIUM PHARMACEUTICALS LTD858352983MANUFACTURE

 
HIMPRIT PHARMACHEM PVT LTD

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Further information

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

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