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SENNA (HIMPRIT PHARMACHEM PVT LTD)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-087-50) > 50000 TABLET, FILM COATED in 1 BAG Label Information

Complete SENNA Information

  • SPL UNCLASSIFIED SECTION

    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
    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

    • 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"

    PRINCIPAL DISPLAY PANEL - Shipping Label

  • INGREDIENTS AND APPEARANCE
    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