Label: SENNAZON- 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 July 31, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each teaspoonful)

    Sennosides 8.8 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation
    • generally produces bowel movement in 6-12 hours
  • Warnings

    Do not use

    • for longer than one week
    • when abdominal pain, nausea or vomiting are present

    Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

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

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have bowel movement after use of this product. 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
    agestarting dosemaximum dosage
    adults and children 12 years and older2 - 3 teaspoons once a day3 teaspoons twice a day
    children 6 to under 12 years1 - 1 1/2 teaspoons once a day1 1/2 teaspoons twice a day
    children 2 to under 6 years1/2 - 3/4 teaspoon once a day3/4 teaspoon twice a day
    children under 2 yearsask a doctorask a doctor
  • Other information

    • avoid excessive heat
    • store at room temperature 15°- 30°C (59°- 86°F)
  • Inactive ingredients

    cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

  • Questions?

    Call 1-855-bay-pharm 9 am - 5 pm EST Monday - Friday

  • SPL UNCLASSIFIED SECTION

    Mfd. for: Bayshore Pharmaceuticals
    Tampa, FL 33619

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    NDC 76518-100-08

    COMPARE TO ACTIVE
    INGREDIENTS IN
    SENOKOT®*

    b
    Protected™

    Sennazon
    Syrup

    Natural Vegetable LAXATIVE

    Alcohol
    Free

    • Natural Chocolate Flavor
    • Standardized Senna Fruit
      Concentrate

    8 fl. oz. (237 mL)

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SENNAZON 
    sennosides a and b syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76518-100
    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)  
    sucrose (UNII: C151H8M554)  
    cocoa (UNII: D9108TZ9KG)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76518-100-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/01/2012
    Labeler - Bayshore Pharmaceuticals LLC [FL] (963298273)
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