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SENNA LEAF and DOCUSATE SODIUM (HIMPRIT PHARMACHEM PVT LTD)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-035-50) > 50000 TABLET, FILM COATED in 1 BAG Label Information
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-035-70) > 75000 TABLET, FILM COATED in 1 BAG Label Information

Complete SENNA LEAF and DOCUSATE SODIUM Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purpose
    Docusate sodium 50 mg Stool softener
    Sennosides 8.6 mg Laxative

  • Uses

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

  • Warnings

    Do not use

    • if you are now taking mineral oil, unless directed by a doctor
    • 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 medical 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

  • Inactive Ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, sodium benzoate, stearic acid, tartaric acid, titanium dioxide


  • PRINCIPAL DISPLAY PANEL - Shipping Label

    SENNA 8.6mg & DOCUSATE SODIUM 50mg
    Orange Tablets

    Each Tablet Contains:
    CALCIUM SENNOSIDES 8.6mg
    DOCUSATE SODIUM 50mg

    Lot No: Quantity:
    Mfg Date: Jar No:
    Exp Date: NDC NO: 65437-035-50

    WARNING:
    KEEP OUT OF THE REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPERATURE OF 59 - 77 F (15 - 25 C)
    PROTECT FROM LIGHT,MOISURE 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 F.D. & C. ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    MANUFACTURED CODE NO Guj/Drugs/G/1362
    LABELLER CODE # 14803

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

    PRINCIPAL DISPLAY PANEL - Shipping Label

  • INGREDIENTS AND APPEARANCE
    SENNA LEAF AND DOCUSATE SODIUM 
    senna leaf and docusate sodium tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-035
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65437-035-50 1 in 1 DRUM
    1 50000 in 1 BAG
    2 NDC:65437-035-70 1 in 1 DRUM
    2 75000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 04/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)