Label: SENNOSIDES capsule, liquid filled

  • 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 May 20, 2020

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

  • Active Ingredient

    (in each softgel)

    Sennosides 17.2 mg

  • Purpose

    Laxative

  • Uses

    ■ relieves occasional constipation (irregularity)

    ■ generally produces a bowel movement within 6-12 hours

  • 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 continues over a period of 2 weeks

  • Stop use and consult 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.

    adults and children 12 years and over

    ■ 1 capsule once a day. Maximum 2 capsules twice a day.

    children 6 to under 12 years

    ■ maximum 1 capsule twice a day

    children under 6 years

    ■ ask a doctor

  • Other information

    ■ store below 30°C and protect from light and moisture

  • Inactive ingredients

    FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, FD&C yellow no.6, fumaric acid, gelatin, glycerol, lecithin, liquid sorbitol, methyl hydroxy benzoate, purified water, refined soya oil, titanium dioxide, yellow bees wax.

  • Questions or comments?

    call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST.

  • Package Label Principal Display Panel

    100 count

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES 
    sennosides capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES17.2 mg  in 17.2 
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    Colorbrown (Maroon coloured, opaque soft gelatin capsules containing dark brown coloured oily mass.) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-016-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/29/2020
    Labeler - Granules USA Inc (137098864)