Label: STOOL SOFTENER- docusate sodium and sennosides tablet, coated

  • NDC Code(s): 63548-4000-1
  • Packager: Avema Pharma Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/10

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  • Active ingredients (in each tablet)

    Docusate Sodium 50 mg*

    Sennosides 8.6 mg**

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  • Purpose

    *Stool softener

    **Stimulant laxative

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  • Uses

    relief of occasional constipation (irregularity). This product generally produces a bowel movement within 6 to 12 hours.

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  • Warnings

    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

    Ask a doctor or pharmacist before use if you are presently taking mineral oil.

    Stop use and ask a doctor if

    • you need to use a laxative for more than 1 week
    • you have no bowel movement or have rectal bleeding. These may be signs of 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

    • doses may be taken as a single dose or in divided doses preferably in the evening
    adults and children 12 years of age and older take 2-4 tablets daily
    children 6 to under 12 years of age take 1-2 tablets daily
    children 2 to 6 years of age take up to 1 tablet daily
    children under 2 years of age ask a doctor
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  • Other information

    • each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
    • each tablet contains: calcium 20 mg/tablet
    • store at 15°-30°C (59°-86°F), protect from excessive moisture
    • 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 Peri-Colace®.
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Red #40 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, sodium benzoate, stearic acid, and titanium dioxide. May also contain: ethanol, FD&C Blue # 2 Aluminum Lake, maltodextrin, mineral oil, Opadry ll Red, pregelatinized starch, silicon dioxide 50s.

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  • Package/Label Principal Display Panel

    Stool Softener Plus Stimulant Laxative 100 Tablets Packaging Label

    NDC 63548-4000-*1

    Compare to the active ingredients of Peri-Colace®*

    STOOL SOFTENER PLUS STIMULANT LAXATIVE

    DOCUSATE SODIUM, 50 MG

    PLUS SENNOSIDES, 8.6 MG

    For Relief of Occasional Constipation

    100 TABLETS

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium and sennosides tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-4000
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 4mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63548-4000-1 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/02/2010
    Labeler - Avema Pharma Solutions (804087749)
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