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 February 6, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

    *Senna Syrup is not manufactured or distributed by The Purdue Frederick Company, owners of the registered trademark Senokot®.

  • 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

    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

    Do not use laxative products for longer than 1 week unless directed by a doctor

    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 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 overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

    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?

    To Report Adverse Drug Event Call (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    Distributed by: MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150 USA

  • HOW SUPPLIED

    Product: 68151-0648

    NDC: 68151-0648-0 5 mL in a PACKAGE

  • Calcium Sennosides

    Label Image
  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides a and b syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-0648(NDC:0904-6289)
    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:68151-0648-05 mL in 1 PACKAGE; Type 0: Not a Combination Product04/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33404/23/2012
    Labeler - Carilion Materials Management (079239644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carilion Materials Management079239644REPACK(68151-0648)
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