Label: SENNA- sennosides a and b syrup

  • 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 April 30, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each teaspoonful)

    Sennosides 8.8 mg

  • Purpose

    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 movements that continues over a period of 2 weeks

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

    If pregnant or breast-feeding, ask a 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.

  • Directions

    • shake well before use
    • Do not exceed recommended dose
    AgeStarting DoseMaximum dosage
    adults and children 12 years and older2 - 3 teaspoons once a day preferable at bedtime; increase as needed or as recommended by a doctor3 teaspoons in the morning and 3 teaspoons at bedtime
    Under 12 years of ageask a doctorask a doctor
  • Other information

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

    TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing.

  • Inactive ingredients

    flavors, parabens, propylene glycol, sucrose, and water.

  • SPL UNCLASSIFIED SECTION

    RIJ Pharmaceuticals Corporation
    40 Commercial Avenue
    Middletown, NY 10941

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    NDC 53807-556-08

    Senna Syrup
    Senna Syrup
    Natural Vegetable Laxative

    8 fl. oz. (237 mL)

    Principal Display Panel - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides a and b syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-556
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sennosides A and B (UNII: 1B5FPI42EN) (Sennosides A and B - UNII:1B5FPI42EN) Sennosides A and B8.8 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    cocoa (UNII: D9108TZ9KG)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-556-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33411/08/2016
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-556)
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