Label: SENNA-S- docusate sodium and sennosides 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 July 30, 2010

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  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Stool softener & Stimulant laxative

  • USES

    • relieves occasional constipation (irregularity)
    • generally causes a bowel movement in 6 to 12 hours
  • WARNINGS

    Do not use

    • this product if you are presently taking mineral oil, unless directed by a doctor
    • laxative products for more than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel habits that persists over 2 weeks

    Stop use and ask a doctor if you have

    • have rectal bleeding
    • fail to have a bowel movement after the use of a laxative

    These could be signs of 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
    • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage); or decrease dose until you are comfortable
    • agestarting dosemaximum dose
      adults and children 12 years and over2 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 20 mg, sodium 6 mg (LOW SODIUM)
    • TAMPER-EVIDENT: Do not use this product if foil seal on back of blister is cut, torn, broken or missing
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENTS

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch1, tartaric acid1, titanium dioxide

    1may contain these ingredients

  • QUESTIONS OR COMMENTS?

    call 1-888-838-2872, weekdays, 8 AM-5 PM Eastern Time

    Distributed by:
    GOLDLINE LABORATORIES, INC.
    Sellersville, PA 18960 Dist. 1999 0110REV 89
    192B R1009

    Repackaged by:

    Contract Pharmacy Services-PA
    125 Titus Ave Suite 200
    Warrington, PA 18976 USA

    Original--08/2010--NJW

  • Package Label

    Blister of 30 Tablets

  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    docusate sodium and sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-670(NDC:0182-1113)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-670-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/17/2010
    Labeler - Contract Pharmacy Services-PA (945429777)
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