Label: SENNA- sennosides capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)                                    Purpose

    Sennosides 8.6 mg..............................................................Laxative

  • Uses

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

    Do not use

    • laxative products for longer than 1 week, unless directed 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 may indicate 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.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    AgeStarting DosageMaximum Dosage
    adults and children 12 years of age or older2 softgels once a day4 softgels twice a day
    children 6 to under 12 years1 softgel once a day2 softgels twice a day
    children under 6 years of ageask a doctorask a doctor
  • Other information

    • each softgel contains: calcium 1 mg and sodim less than 1  mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No.6, gelatin, glycerin, light liquid paraffin, purified water, sodium carboxymethyl cellulose, sorbitol solution, soya lecithin, titanium dioxide

  • Questions?

    Call 1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - CVS SENNA 60 Softgels Bottle Carton

    ♥CVSHealth ™

    Compare to the active
    ingredient in Senokot ®*

    Liquid Filled Softgels†

    NDC 69842-320-60

    Senna
    SENNOSIDES, 8.6 mg
    Laxative

    Standardized senna concentrate

    Natural vegetable

    laxative ingredient

    60 SOFTGELS

    Actual Product Size

    on Bottom Panel

    PRINCIPAL DISPLAY PANEL - CVS SENNA 60 Softgels Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (Opaque) Scoreno score
    ShapeCAPSULE (SOFTGEL) Size12mm
    FlavorImprint Code 458
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-320-601 in 1 CARTON03/14/2018
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/14/2018
    Labeler - CVS (062312574)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LTD677385498manufacture(69842-320)
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