Label: CHOCOLATED LAXATIVE- sennosides bar, chewable

  • 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 March 1, 2018

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  • ACTIVE INGREDIENT

    Sennosides USP 15mg

  • INACTIVE INGREDIENT

    sugar, partially hydrogenetated palm kernel and cotton seed oils, non-fat dry milk, cocoa, milk, gyceryl lacto esters of fatty acids, soy lecithin, cocoa butter.

  • DOSAGE & ADMINISTRATION

    adults and children 12 years of age and overchew 2 pieces once or twice daily
    children 6 to under 12 years of agechew 1 piece once or twice daily
    children under 6 years of ageask a doctor

  • INDICATIONS & USAGE

    * relieves occasional constipation (irregularity)
    * generally produces bowel movement in 6 to 12 hours

  • WARNINGS

    Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.

    Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.

    Ask a doctor or Pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

    When using this product * do not use for a period longer than 1 week.

    Stop use and ask a doctor if * rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

    If pregnant or breast-feeding,ask a health professional before use.

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Stimulant laxative

  • OTHER SAFETY INFORMATION

    * contains milk and soy ingredients

    * gluten free

    * store at 15°C - 25°C (59°F-77°F)

  • PRINCIPAL DISPLAY PANEL

    Chocolated Laxative

  • INGREDIENTS AND APPEARANCE
    CHOCOLATED LAXATIVE 
    sennosides bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES15 mg
    Inactive Ingredients
    Ingredient NameStrength
    COW MILK (UNII: 917J3173FT)  
    GLYCERYL LACTOPALMITATE/STEARATE (UNII: 41BQ90M326)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SKIM MILK (UNII: 6A001Y4M5A)  
    SUCROSE (UNII: C151H8M554)  
    HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    COCOA (UNII: D9108TZ9KG)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeRECTANGLESize70mm
    FlavorCHOCOLATEImprint Code SC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-400-1010 in 1 PACKAGE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)