Label: CAREALL SENNA-S LAXATIVE- docusate sodium, sennosides tablet

  • NDC Code(s): 51824-054-01, 51824-054-02
  • Packager: New World Imports, Inc.
  • 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 October 1, 2019

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

  • Active Ingredient

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Laxative

  • Uses

    • relieves occasional constipation (irregularity).
    • generally causes bowel movement within 6 to 12 hours.
  • Warnings

    Do not use:

    ​This product is you are presently taking mineral oil, unless directed by a doctor. 

    Laxative products for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if you have:

    Stomach pain, nausea, vomiting, a sudden change in bowel movements that persists 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.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • taken preferably at bedtime or as directed by a doctor.  If you don't have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable.
    AgeStarting DoseMaximum Dosage
    adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
    children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
    children 2 to 6 years of age1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor

  • Other information

    • each tablet contains: sodium 6 mg/tablet LOW SODIUM
    • each tablet contains: calcium 20 mg/tablet
    • store at 15°-30°C (59°-86°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 Pharma L.P., owner of the registered trademark Senokot S.
  • Inactive ingredients

    carnauba was, croscarmellos sodium, D and C yellow number 10 aluminum lake, dibasic calcium phosphate dihydrate, FD and C yellow number 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethlene glycol, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    SENS60 Label.jpg

  • INGREDIENTS AND APPEARANCE
    CAREALL SENNA-S LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-054
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-054-0224 in 1 CASE04/18/2016
    1NDC:51824-054-0160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/18/2016
    Labeler - New World Imports, Inc. (075372276)