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

  • NDC Code(s): 51645-850-01, 51645-850-06, 51645-850-10, 51645-850-99
  • Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharma
  • 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 June 27, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

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  • PURPOSE

    Purposes

    Stool softener

    Laxative

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  • INDICATIONS & USAGE

    Uses

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

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  • DOSAGE & ADMINISTRATION

    Directions

    • take preferably at bedtime or as directed by a doctor
    age starting dose maximum 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
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  • 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
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  • 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.

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  • QUESTIONS

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

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    NDC 51645-850-10

    Plus PHARMA

    Senna Plus

    Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each

    Vegetable Laxative Ingredient Plus Stool Softener

    Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

    *Compare to the Active Ingredients in Senokot-S®

    *Plus Pharma is not affiliated with the owner of the registered trademark Senokot-S®

    1000 TABLETS

    Plus Pharma Senna Plus

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  • INGREDIENTS AND APPEARANCE
    PLUS PHARMA SENNA PLUS  STANDARDIZED SENNA CONCENTRATE 8.6 MG AND DOCUSATE SODIUM 50 MG EACH
    docusate sodium,sennosides tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51645-850
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND (Biconvex) Size 10mm
    Flavor Imprint Code G55
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51645-850-06 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2006
    2 NDC:51645-850-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2006
    3 NDC:51645-850-99 10 in 1 CARTON 03/27/2006
    3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:51645-850-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2006
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/27/2006
    Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270 manufacture(51645-850)
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