SENNA- senna tablet, film coated 
HIMPRIT PHARMACHEM PVT LTD

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

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

age starting dosage maximum dosage
adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Other information

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"

PRINCIPAL DISPLAY PANEL - Shipping Label
SENNA 
senna tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-087
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNA (UNII: AK7JF626KX) (SENNA - UNII:AK7JF626KX) SENNA 8.6 mg
Inactive Ingredients
Ingredient Name Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code S8
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65437-087-50 1 in 1 DRUM
1 50000 in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part334 11/20/2009
Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
Registrant - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
Name Address ID/FEI Business Operations
ELYSIUM PHARMACEUTICALS LTD 858352983 MANUFACTURE

Revised: 11/2009
Document Id: f06df412-c097-4acc-a2d3-277aaeb3b17a
Set id: ea14be82-1d4d-41fe-9e2f-3f4df9393be5
Version: 2
Effective Time: 20091111
 
HIMPRIT PHARMACHEM PVT LTD