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 2, 2013

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  • OTC - ACTIVE INGREDIENT

    Docusate sodium 50 mg, Sennoside 8.6 mg.

  • OTC - PURPOSE

    Stimulant laxative.

  • INDICATIONS AND USAGE

    For temporary relief of occasional constipation and irregularity.

    This product generally produces bowel movement in 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 DOCTOR

    Before use if you have:

    Stomach pain, nausea or vomiting

    Noticed a sudden change in bowel habits that lasts over 2 weeks.

  • OTC - STOP USE

    If you have rectal bleeding or fail to have bowel movement after use of a laxative. This could be a serious condition.

  • OTC - PREGNANCY 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

    Drink with a full glass of water with each dose

    Adults and children 12 years and overtake 2 - 4 tablets daily
    Children 6 to under 12 yearstake 1 - 2 tablets daily
    Children 2 to under 6 yearstake up to 1 tablet daily
    Children under 2 years of ageAsk a doctor

    OTHER INFORMATION

    Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM.

    Do not use if the imprinted safety seal under cap is missing or damaged.

    Store at at 25°C (77°F); excursions permitted between 15(-30(C (59(-86(F)

    Keep tightly closed.

  • INACTIVE INGREDIENT

    Colloidal silicon dioxide, dicalcium phosphate, ethanol, FD&C blue #2, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    d08a4708-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:11534-134
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S134
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11534-134-6060 in 1 BOTTLE
    2NDC:11534-134-0557603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/26/2007
    Labeler - Sunrise Pharmaceutical Inc (168522378)
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