Label: SENNA PLUS STANDARDIZED SENNA CONCENTRATE 8.6 MG AND DOCUSATE SODIUM 50 MG EACH- docusate sodium,sennosides tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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 December 29, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Purposes

    Stool softener

    Laxative

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    Do not use

    • if you are now taking mineral oil, unless directed by a doctor
    • laxative products for longer than 1 week unless 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 or fail to have a bowel movement after use of a laxative.

    These may indicate a serious condition.

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

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

  • DOSAGE & ADMINISTRATION

    Directions

    • take preferably at bedtime or as directed by a doctor
    agestarting dosemaximum dose
    adults and children 12 years and older
    		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
  • SPL UNCLASSIFIED SECTION

    Other information

    • each tablet contains: calcium 20 mg
    • each tablet contains: sodium4 mg
    • store at room temperature in a dry place
    • keep lid tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

  • QUESTIONS

    Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by:

    Plus Pharma

    Commack, NY 11725

    Manufactured in a GMP facility in the USA

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    SENNA PLUS  STANDARDIZED SENNA CONCENTRATE 8.6 MG AND DOCUSATE SODIUM 50 MG EACH
    docusate sodium,sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-938(NDC:51645-850)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUND (Biconvex) Size10mm
    FlavorImprint Code G55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45865-938-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/27/2006
    Labeler - medsource pharmaceuticals (833685915)
    Establishment
    NameAddressID/FEIBusiness Operations
    medsource pharmaceuticals833685915repack(45865-938)
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