Label: SENNA SYRUP- sennosides liquid

  • 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 September 20, 2022

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  • ACTIVE INGREDIENT

    Senna Syrup

    Active ingredient

    (in each 5 mL teaspoonful)

    Sennosides - 8.8 mg

  • PURPOSE

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally causes bowel movement in 6 to 12 hours
  • WARNINGS

    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 or vomitting
    • noticed a change in bowel habits that lasts over two weeks.

    Stope use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition.

  • PREGNANCY

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well before using
    • Do not exceed recommended dose
    AgeStarting DoseMaximum Dose
     adults and children 12 years and older 2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoonfuls in the morning and 3 teaspoonfuls at bedtime
    Under 12 years of age ask a doctor ask a doctor

  • STORAGE AND HANDLING

    Other information

    • store at room temperature 15° to 25° C (59° to 77° F)

    TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.

  • INACTIVE INGREDIENT

    Inactive ingredients:artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose.

  • QUESTIONS

    Questions or comments?

    Call 1-844-474-7464

  • PRINCIPAL DISPLAY PANEL

    sennalabel01

  • INGREDIENTS AND APPEARANCE
    SENNA SYRUP 
    sennosides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.8 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorbrown (Brown to dark brown) Score    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-301-24237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/27/2022
    Labeler - Rising Health, LLC (080500961)
    Establishment
    NameAddressID/FEIBusiness Operations
    Invahealth Inc.116840615analysis(57237-301) , label(57237-301) , manufacture(57237-301) , pack(57237-301)
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