Label: DOCUZEN- sennosides 8.6mg and docusate sodium 50mg tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 27, 2018

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  • Active Ingredients (in each tablet)

    Sennosides from Senna Concentrate 8.6mg

    Docusate Sodium 50mg

  • Purpose

    Laxative

    Stool Softner

  • Uses

    •
    relieves occasional constipation (irregularity)
    •
    generally produces a bowel movement in 6-12 hours
  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    •
    stomach pain
    •
    nausea
    •
    vomiting
    •
    noticed a sudden change in bowel habits that continues over a period of 2 weeks

    Stop use and ask a doctor if

    •
    you have rectal bleeding 
    •
    you 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 healthcare professional before use. 

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

  • Directions

    •
    take preferably at bedtime or as directed by a doctor

    age

    starting dosage

    maximum dosage

    Adults and children 12 years and over

    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
  • Other information

    •
    each tablet contains 10 mg of calcium, sodium 5 mg
    •
    store at 25°C (77°F); excursions permitted between 15o-30oC (59o-86oF)
  • Inactive ingredients

    croscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc & titanium dioxide.

  • Questions or comments?

    1-800-828-0464 Mon-Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    VillagePharma

    NDC 71574-700-60

    DOCUZEN

    Sennosides 8.6mg &

    Docusate Sodium 50mg

    60 TABLETS

    Manufactured in the USA

    image of Label
  • INGREDIENTS AND APPEARANCE
    DOCUZEN 
    sennosides 8.6mg and docusate sodium 50mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71574-700-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/27/2018
    Labeler - Village Pharma (080749749)
    Registrant - Village Pharma (080749749)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(71574-700) , pack(71574-700) , analysis(71574-700)
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