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 August 7, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

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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

    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.

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  • Directions

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

    age starting dose maximum dosage

    adults and children 12 years and older

    2 - 3 teaspoons once a day

    3 teaspoons twice a day

    children 6 to under 12 years

    1 - 1 1/2 teaspoons once a day

    1 1/2 teaspoons twice a day

    children 2 to under 6 years

    1/2 - 3/4 teaspoon once a day

    3/4 teaspoon twice a day

    children under 2 years

    ask a doctor

    ask a doctor

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  • Other information

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

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

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  • Questions?

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

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    MAJOR®

    NDC 0904-6289-09

    NEW &
    IMPROVED

    Senna SYRUP
    Natural Vegetable Laxative

    For Gentle, Predictable Relief
    of Constipation

    (standardized extract of senna fruit)

    Alcohol Free

    Natural Chocolate Flavor

    Contents:
    8 fl. oz. (237 mL)

     
    Compare to active ingredient in
    Senokot ®*
    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:0904-6289
    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:0904-6289-09 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2012 10/13/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 04/23/2012 10/13/2019
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Major Pharmaceuticals (191427277)
    Establishment
    Name Address ID/FEI Business Operations
    Major Pharmaceuticals 191427277 REPACK(0904-6289)
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