Label: SENNA tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 11, 2009

If you are a consumer or patient please visit this version.

View All Sections
  • 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
    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"

    PRINCIPAL DISPLAY PANEL - Shipping Label
  • INGREDIENTS AND APPEARANCE
    SENNA 
    senna tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-087
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNA (UNII: AK7JF626KX) (SENNA - UNII:AK7JF626KX) SENNA8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65437-087-501 in 1 DRUM
    150000 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/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LTD858352983MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!