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

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 02/10

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

    **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 LABEL Item Code (Source) NDC:63548-4000
    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
    CROSCARMELLOSE SODIUM  
    SILICON DIOXIDE  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    HYPROMELLOSE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    MEDIUM-CHAIN TRIGLYCERIDES  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    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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