Label: SENNA/DOCUSATE SODIUM- 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 April 20, 2012

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    TAMPER-EVIDENT: Do not use this product if imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each tablet)    		Purposes
    Docusate sodium 50 mgStool softener
    Sennosides 8.6 mgStimulant laxative
  • PURPOSE

    Purposes
    Docusate sodium 50 mgStool softener
    Sennosides 8.6 mgStimulant laxative
  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes 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 longer 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 rectal bleeding
    • fail to have a bowel movement after 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 overodse, 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 dosagemaximum dosage
    adults and children 12 years and 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 20 mg, sodium 6 mg (LOW SODIUM)
    • store at room temperature 15° to 30°C (59° to 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

    1
    may contain these ingredients
  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    †This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®

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



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle

    PRINCIPAL DISPLAY PANEL - 100 Tablet Carton

    NDC 54868-4917-0

    TAMPER-EVIDENT

    Senna/Docusate Sodium Tablets
    (brand of standardized senna concentrate
    equivalent to 8.6 mg sennosides
    and docusate sodium 50 mg)

    Natural Vegetable Stimulant
    Laxative And Stool Softener

    100 TABLETS

    Compare to active ingredients
    of Senokot-S® Tablets†


  • INGREDIENTS AND APPEARANCE
    SENNA/DOCUSATE SODIUM 
    docusate sodium and sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4917(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)  
    hypromelloses (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
    ColorORANGEScoreno score
    ShapeROUND (bi-convex) Size10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-4917-0100 in 1 BOTTLE, PLASTIC
    2NDC:54868-4917-160 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33409/11/2003
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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!