Label: SENNA- sennosides a and b syrup

  • NDC Code(s): 53807-556-08
  • Packager: Rij Pharmaceutical Corporation
  • 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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient (in each teaspoonful)

    Sennosides 8.8 mg

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  • Purpose

    Laxative

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6-12 hours
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  • 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.

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  • Directions

    • shake well before use
    • Do not exceed recommended dose
    Age Starting Dose Maximum dosage
    adults and children 12 years and older 2 - 3 teaspoons once a day preferable at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime
    Under 12 years of age ask a doctor ask a doctor
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  • 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.

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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    RIJ Pharmaceuticals Corporation
    40 Commercial Avenue
    Middletown, NY 10941

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  • 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
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  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides a and b syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-556
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sennosides A and B (UNII: 1B5FPI42EN) (Sennosides A and B - UNII:1B5FPI42EN) Sennosides A and B 8.8 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    cocoa (UNII: D9108TZ9KG)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    Color BROWN Score     
    Shape Size
    Flavor CHOCOLATE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53807-556-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/08/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 11/08/2016
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    Name Address ID/FEI Business Operations
    Rij Pharmaceutical Corporation 144679156 manufacture(53807-556)
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