Label: SENNA 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 June 8, 2022

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  • Active Ingredient

    Active ingredient (in each 5 ml) purpose
    Sennosides 8.8 mg …………………………................Laxative

  • Uses

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

  • Directions

    shake well before use
    take preferably at bedtime or as directed by a doctor

  • DOSAGE & ADMINISTRATION

    Age                                                                   Starting Dose                           Maximum Dose
    adults and children                                   12 years 2 - 3 teaspoonfuls         3 teaspoonfuls twice a day
    and older once a day


    6 years to under 12 years of age              1 - 1½ teaspoonfuls once a day       1½ teaspoonfuls twice a day

    2 to under 6 years of age                       ½ - ¾ teaspoon once a day                 ¾ teaspoon once a day

    under 2 years of age consult a doctor consult a doctor

  • Warnings

    Do Not Use • laxative products for longer than 1 week
    unless directed by a doctor
    Ask a doctor or pharmacist before use if you have
    • stomach pain • nausea • vomiting
    • notice a sudden change in bowel movement that continues
    over a period of 2 weeks
    Stop 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
    If pregnant or breast-feeding, ask a health
    professional before use

  • Other Information

    • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)
  • Inactive Ingredients

    Mythylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucrose

  • KEEP OUT OF REACH OF CHILDREN SECTION

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately

    Questions?

    To Report Adverse Drug Event Call 1(877) 225-6999

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP. 

    20101 N.E 16TH PLACE 

    MIAMI, FL 33179

  • PRINCIPAL PANEL 

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  • INGREDIENTS AND APPEARANCE
    SENNA 
    senna syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-8237(NDC:71399-8237)
    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 B417.12 mg  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-8237-172 in 1 BOX, UNIT-DOSE05/04/2020
    1NDC:17856-8237-65 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-8237-572 in 1 BOX, UNIT-DOSE05/04/2020
    210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:17856-8237-3120 in 1 BOX, UNIT-DOSE05/04/2020
    3NDC:17856-8237-72.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    4NDC:17856-8237-448 in 1 BOX, UNIT-DOSE05/04/2020
    4NDC:17856-8237-85 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/25/2019
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-8237)
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