Label: PERI-COLACE- docusate sodium and sennosides tablet, film coated 

  • Label RSS
  • NDC Code(s): 67618-106-04, 67618-106-10, 67618-106-30, 67618-106-60
  • Packager: Purdue Products LP
  • 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 09/13

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

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 12 hours
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  • WARNINGS
  • Do not use

    • laxative products for longer than 1 week unless told to do so by a doctor
    • if you are presently taking mineral oil, unless told to do so by a doctor
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  • Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks
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  • ASK DOCTOR/PHARMACIST

    Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Directions

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

    • each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

       Keep tightly closed.

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  • Inactive ingredients

    dicalcium phosphate, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

    ©2013, Purdue Products L.P.

    Mfd. for: Purdue Products L.P.
    Stamford, CT 06901-3431

    By: Purdue Pharma, 575 Granite Court
    Pickering, ON L1W 3W8, Canada
    303048-0A




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  • PRINCIPAL DISPLAY PANEL

    Peri-Colace® Tablets
    NDC: 67618-106-30

    303048-0A
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  • INGREDIENTS AND APPEARANCE
    PERI-COLACE 
    docusate sodium - sennosides tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67618-106
    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
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C RED NO. 40  
    FD&C BLUE NO. 2  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    STARCH, CORN  
    SODIUM BENZOATE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED (burgundy) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code P054
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67618-106-04 1 in 1 CARTON
    1 4 in 1 BLISTER PACK
    2 NDC:67618-106-10 2 in 1 CARTON
    2 5 in 1 BLISTER PACK
    3 NDC:67618-106-30 1 in 1 CARTON
    3 30 in 1 BOTTLE, PLASTIC
    4 NDC:67618-106-60 1 in 1 CARTON
    4 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 02/08/1957
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    Name Address ID/FEI Business Operations
    Purdue Pharma 250955291 PACK(67618-106), MANUFACTURE(67618-106)
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