Label: SENNA- sennosides tablet

  • NDC Code(s): 68016-117-00
  • Packager: Chain Drug Consortium, LLC (Premier Value)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • Active Ingredient (in each tablet)

    Sennosides 8.6 mg

    Purpose

    Laxative

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement within 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 using 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 a bowel movement after use of a laxative. 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.

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  • Directions

    • Take preferably at bedtime or as directed by a doctor

     age

     starting dosage  maximum dosage
     adults and children 12 years of age or older  2 tablets once a day  4 tablets twice a day
     children 6 to under 12 years  1 tablet once a day  2 tablets twice a day
     children 2 to under 6 years  1/2 tablet once a day  1 tablet twice a day
     children under 2 years  ask a doctor  ask a doctor


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  • Other information


    • each tablet contains: calcium 25 mg/ tablet
    • store at 25o C (77o F); excursions permitted between 15o - 30o C (59o-86o F)
    • do not use if imprinted safety seal under cap is broken or missing.
    • **This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Senokot®
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  • Inactive Ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, dicalcium phosphate*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil, polyethylene glycol*, purified water*, silicon dioxide*, stearic acid*, talc*, and triacetin*

    *contains one or more of these ingredients

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  • Questions or comments?

    call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

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  • Principal Display Panel

    **Compare to the active ingredient in senokot®

    Senna

    Sennosides 8.6 mg

    Standardized senna concentrate

    Natural vegetable laxative

    Relieves occasional constipation

    Distributed by:

    CHAIN DRUG CONSORTIUM, LLC

    3301 NW BOCA RATON BLVD. SUITE 101

    BOCA RATON, FL 33431

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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  • Product Labeling

    Premier Value Senna 8.6 mg

    Sennosides 8.6 mg

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  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68016-117
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POLYETHYLENE GLYCOLS  
    WATER  
    SILICON DIOXIDE  
    STEARIC ACID  
    TALC  
    TRIACETIN  
    Product Characteristics
    Color BROWN (BROWN) Score no score
    Shape ROUND (ROUND) Size 9mm
    Flavor Imprint Code S3;TLC080;S8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-117-00 1 in 1 BOX
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 04/18/2011
    Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460)
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