Label: STOOL SOFTENER AND STIMULANT LAXATIVE- docusate sodium and sennosides tablet

  • NDC Code(s): 41520-022-01
  • 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 08/13

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

    Stimulant laxative

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  • Uses

    • for overnight relief from occasional constipation (irregularity)
    • generally produces bowel movement in 6 to12 hours
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  • 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

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 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 could be signs of 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
     adults and children 12 years and over
     take 2-4 tablets daily 
     children 6 to under 12 years of age  take 1-2 tablets daily 
     children 2 to under 6 years of age  take up to 1 tablet daily 
     children under 2  ask a doctor 
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  • Other Information

    • each tablet contains: calcium 20 mg
    • each tablet contains: sodium 6 mg VERY LOW SODIUM
    • store at 15º-30ºC (59º-86ºF), protect from excessive moisture
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  • Inactive ingredients

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

    *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 Peri-Colace®** 

    STOOL SOFTENER & STIMULANT LAXATIVE

    Docusate sodium, 50 mg

    Sennosides, 8.6 mg

    A GENTLE, PREDICTABLE LAXATIVE

    TABLETS

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD  20785

    1-877-846-9949

    ©2013 S&S Brands LLC

    Quality guaranteed or your money back.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    **This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Peri-Colace®

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  • Product Label

    Care One

    Stool softener plus stimulant laxative tablets

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  AND STIMULANT LAXATIVE
    docusate sodium and sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-022
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
    SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    WATER  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    ALUMINUM OXIDE  
    POLYDEXTROSE  
    C10-18 TRIGLYCERIDES  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code TCL97;SS2;S44
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-022-01 1 in 1 BOX
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 03/01/2013
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
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