Label: SENNA 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 August 7, 2013

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

View All Sections
  • OTC - ACTIVE INGREDIENT

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • OTC - PURPOSE

    Stool softener and Stimulant laxative

  • INDICATIONS AND USAGE

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

    Do not use:

    • laxative products for longer than 1 week unless told to do so by a doctor
    • if you are presently taking mineral oil, unless told to do so by a doctor
  • OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE

    • Stomach pain
    • Nausea
    • Vomiting
    • Noticed a sudden change in bowel habits that lasts over 2 weeks
  • OTC - STOP USE AND ASK A DOCTOR IF

    You have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

  • OTC – IF PREGNANT OR BREAST FEEDING

    Ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE AND ADMINISTRATION

    • 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 years  1 tablet once a day2 tablets twice a day
    children 2 to under 6 years ½ tablet once a day1 tablet twice a day
    children under 2 years ask a doctorask a doctor
  • OTHER INFORMATION

    • Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM
    • Do not use if imprinted safety seal under cap is missing or damaged.
    • Store at 25° C (77° F); excursions permitted between 15° C-30° C (59° -86° F).
    • Keep tightly closed.
  • INACTIVE INGREDIENT

    Colloidal silicon dioxide, dicalcium phosphate, D&C yellow No 10 Aluminum Lake, ethanol, FD&C yellow No 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, mineral oil,  polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    dda29277-figure-01
  • INGREDIENTS AND APPEARANCE
    SENNA AND DOCUSATE SODIUM 
    senna and docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-090
    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
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S90
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11534-090-6060 in 1 BOTTLE
    2NDC:11534-090-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/26/2007
    Labeler - Sunrise Pharmaceutical Inc (168522378)
    Registrant - Sunrise Pharmaceutical Inc (168522378)
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!