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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 1, 2021

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

  • 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

    NDC 71205-282-60

    DOCUZEN

    Sennosides 8.6mg &

    Docusate Sodium 50mg

    60 TABLETS

    Manufactured in the USA

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    71205-282-60
  • INGREDIENTS AND APPEARANCE
    DOCUZEN 
    sennosides 8.6mg and docusate sodium 50mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-282(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:71205-282-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
    2NDC:71205-282-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
    3NDC:71205-282-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/27/2018
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-282) , RELABEL(71205-282)