Label: SENNOSIDES capsule, liquid filled

  • NDC Code(s): 35916-0423-1, 35916-0423-2
  • Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
  • 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 January 10, 2023

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  • Actice ingredient

    (in each softgel)
    Sennosides 17.2 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement within 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 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 (86°F) 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

  • PRINCIPAL DISPLAY PANEL

    Shipper labelPack label

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES 
    sennosides capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0423
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES17.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FUMARIC ACID (UNII: 88XHZ13131)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    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:35916-0423-11000 in 1 BAG; Type 0: Not a Combination Product05/29/2019
    2NDC:35916-0423-22000 in 1 BOX; Type 0: Not a Combination Product05/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/29/2019
    Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0423)
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