Label: SENOKOT-S- sennosides and docusate sodium tablet 

  • Label RSS
  • NDC Code(s): 67618-310-01, 67618-310-04, 67618-310-30, 67618-310-60
  • Packager: Purdue Products LP
  • 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 09/13

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  • INDICATIONS & USAGE

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate sodium         50 mg

    Sennosides                      8.6 mg

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  • PURPOSE

    Purpose

    Stool softener

    Laxative

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  • WHEN USING

    Uses

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

    Warnings

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  • DO NOT USE

    Do not use

    • if you are now taking mineral oil, unless directed by a doctor
    • laxative products for longer than 1 week unless directed by a doctor
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  • ASK 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
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  • STOP USE

    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.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    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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  • DOSAGE FORMS & STRENGTHS

    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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  • HOW SUPPLIED

    Other information

    • each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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  • INACTIVE INGREDIENT

    Inactive ingredients


    Inactive ingredients dicalcium phosphate,D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, lecithin, magnesium stearate ,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

    ©2012, Purdue Products L.P.

    Manufactured for:
    Purdue Products L.P.
    Stamford, CT 06901-3431

    By:
    Purdue Pharma
    575 Granite Court
    Pickering, ON L1W 3W8, Canada

    302887-0A

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  • PRINCIPAL DISPLAY PANEL

    Senokot-S 60 Tablets Carton
    NDC: 67618-310-60

    302887-0A
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  • INGREDIENTS AND APPEARANCE
    SENOKOT-S 
    standardized senna concentrate and docusate sodium tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67618-310
    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
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    EGG PHOSPHOLIPIDS  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    STARCH, CORN  
    SODIUM BENZOATE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code P
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67618-310-04 4 in 1 BLISTER PACK
    2 NDC:67618-310-01 1 in 1 CARTON
    2 10 in 1 BLISTER PACK
    3 NDC:67618-310-30 1 in 1 CARTON
    3 30 in 1 BOTTLE, PLASTIC
    4 NDC:67618-310-60 1 in 1 CARTON
    4 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 10/01/1974
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    Name Address ID/FEI Business Operations
    Purdue Pharma 250955291 MANUFACTURE(67618-310)
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