Label: SENNA-S LAXATIVE- docusate sodium and sennosides tablet

  • NDC Code(s): 51824-026-01
  • Packager: New World Imports, Inc.
  • 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 12/12

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

  • Active ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

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  • Purpose

    Stool softener

    Laxative

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  • Uses

    • relieves occasional constipation (irregularity).
    • generally causes bowel movement within 6 to 12 hours.
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  • Warnings

    Do not use

    • if you are now taking mineral oil, unless directed by a doctor
    •  laxative products for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel habits that lasts 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 the use of a laxative. These may indicate a serious condition.

    If pregnant or breast-feeding, ask a health care 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

    • taken preferably at bedtime or as directed by a doctor
    Age
    Starting Dose
    Maximum Dosage
    adults and children 12 years of age and older 2 tablets once a day
    4 tablets twice a day
    children 6 to under 12 years of age 1 tablet once a day
    2 tablets twice a day
    children 2 to 6 years of age 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: sodium 6 mg/tablet LOW SODIUM
    • each tablet contains: calcium 20 mg/tablet
    • store at 15°-30°C (59°-86°F),in well closed containers
    • do not use if imprinted safety seal under cap is broken or missing
    • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot S.
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  • Inactive ingredients

    carnauba wax*, croscarmellose sodium, DandC Yellow 10 Aluminum Lake, dibasic calcium phosphate dihydrate, FDandC Blue 2 Aluminum Lake*, FDandC Red 40 Aluminum Lake*, FDandC Yellow 6 Aluminum Lake, hypromellose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, sodium benzoate*, stearic acid, titanium dioxide

    *may also contain

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  • Product Labeling

    NDC 51824-026-01

    Compare to the active ingredients of Senokot-S®*

    SENNA-S LAXATIVE
    Natural Vegetable Laxative

    Stool softener plus laxative

    60 Docusatee Sodium, 50 mg
    Sennosides, 8.6 mg Tablets

    You may report serious side effcts to:

    Distributed by

    NWI, Inc 160 Athens Way
    Nashville, TN 37228

    Stool Softner plus Laxative 100 tablet label

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  • INGREDIENTS AND APPEARANCE
    SENNA-S LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51824-026
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
    SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    WATER  
    SODIUM BENZOATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code TCL081
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-026-01 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 12/01/2012
    Labeler - New World Imports, Inc. (075372276)
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