Label: SENNA S- sennosides and docusate sodium tablet

  • NDC Code(s): 41520-182-60
  • Packager: Care One (American Sales Company)
  • 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 12/12

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

  • Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

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  • Purpose

    Stool softener

    Laxative

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes bowel movement in 6-12 hours
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  • Warnings
  • 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 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 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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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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 or older 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: sodium 6 mg/tablet LOW SODIUM
    • each tablet contains: Calcium 20 mg/tablet
    • store at 15o- 30o C (59o-86o F) in well closed containers
    • do not use if imprinted safety seal under cap is broken or missing
    • **This product is not manufactured or distributed by Purdue products L.P., owner of the registered trademark Senokot-S®
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  • Inactive ingredients

    carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate, stearic acid, talc*, titanium dioxide

    *contains one or more of these ingredients

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  • Questions or comments?

    Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

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  • Principal Display Panel

    Compare to the active ingredients in Senokot- S® **

    SENNA-S

    Laxative/ Stool softener

    Standardized senna concentrate 8.6 mg and Docusate Sodium 50 mg

    Natural vegetable laxative ingredient plus stool softener

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by: American Sales Company

    4201 Walden avenue, Lancaster, NY 14086

    www.care1.com

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  • Product Label

    CareOne

    Senna-S Laxative/stool softener

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  • INGREDIENTS AND APPEARANCE
    SENNA S 
    docusate sodium and sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-182
    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  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    WATER  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code TCL081;SS1;S35
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-182-60 1 in 1 BOX
    1 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/15/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
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