Label: STOOL SOFTENING SENNA LAXATIVE- sennosides 8.6 mg - docusate sodium 50 mg tablet

  • Category: HUMAN OTC DRUG LABEL

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 February 28, 2019

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  • ACTIVE INGREDIENTS

    Each Tablet contains:

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • INACTIVE INGREDIENTS

    INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake, fd&c yellow#6 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

  • INDICATIONS AND USAGE

    Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

  • PURPOSE

    Stimulant Laxative and Stool Softener

  • DOSAGE AND ADMINISTRATION

    Directions:

    Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

    Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day

    Children 6 to under 12 years: - Starting dosage: 1 tablet once a day-Maximum dosage: 2 tablets twice a day

    Children 2 to under 6 years - Starting dosage: 1/2 tablet once a day- Maximum dosage: 1 tablet twice a day

    Children under 2 years - Ask a doctor

  • WARNINGS

    WARNINGS:

    Do not use this product

    If you are presently taking mineral oil unless directed by a doctor

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

  • PREGNANT OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    192R 30CT BOX

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENING SENNA LAXATIVE 
    sennosides 8.6 mg - docusate sodium 50 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-192
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-192-0330 in 1 BOTTLE; Type 0: Not a Combination Product03/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/29/2019
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(11673-192)
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