Label: SENNA LEAF AND DOCUSATE SODIUM tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 5, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Docusate sodium 50 mgStool softener
    Sennosides 8.6 mgLaxative
  • 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
    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
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-035
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorORANGEScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65437-035-501 in 1 DRUM
    150000 in 1 BAG
    2NDC:65437-035-701 in 1 DRUM
    275000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33404/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
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