Label: SENNA-S- sennosides and docusate sodium tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • Active Ingredients

    Sennosides from Senna Concentrate 8.6 mg

    Sodium Dioctylsulfosuccinate 50 mg

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  • Purposes

    Sennosides from Senna Concentrate 8.6 mg...........Laxative
    Sodium Dioctylsulfosuccinate 50 mg......................Stool Softener

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  • Uses

    • Relieves occasional constipation (irregularity)
    • Generally produces a bowel movement in 6-12 hours.
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  • Warnings

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor
    • if you are now taking mineral oil, 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 medical help or contact a Poison Control Center right away.

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  • Directions

    • take preferably at bedtime or as directed by a doctor

    age starting dosage maximum dosage
    adults and children 12 years of age and over
    2 tablets once a day
    4 tablets twice a day
    children 6 to under 12 years
    1 tablet once a day
    2 tablets twice a day
    children 2 to under 6 years
    1/2 tablet once a day
    1 tablet twice a day
    children under 2 years
    ask a doctor
    ask a doctor
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  • Other Information

    • each tablet contains calcium 20 mg, sodium 6mg Low Sodium
    • store at room temperature between 15-300C (59-860F)
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapoica starch, tartaric acid, titanium dioxide

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  • Questions? Adverse drug event call: (866) 562-2756
  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    sennosides and docusate sodium tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-019
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    SODIUM BENZOATE  
    STEARIC ACID  
    STARCH, TAPIOCA  
    TARTARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color orange (orange) Score no score
    Shape ROUND (round shape) Size 10mm
    Flavor Imprint Code S90
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-019-60 1 in 1 CARTON
    1 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 05/10/2011
    Labeler - Kinray Inc. (012574513)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest Pharmaceutical Inc. 557054835 repack(61715-019), relabel(61715-019)
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