Label: PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH- sennosides tablet, film coated

  • NDC Code(s): 51645-851-01, 51645-851-10, 51645-851-99
  • 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 March 27, 2006

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

  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • 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

    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.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    agestarting dosagemaximum dosage
    adults and children 12 years of age and older
    2 tablets once a day
    4 tablets twice a day
    children 6 to under 12 years of age
    1 tablet once a day
    2 tablets twice a day
    children 2 to under 6 years of age
    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: Calcium 20 mg
    • Store at room temperature
    • Do not use if imprinted seal under cap is broken or missing
  • Inactive ingredients

    Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

  • Questions?

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

  • Principal Display Panel

    NDC 51645-851-01

    PlusPHARMA

    Senna

    Standardized Senna Concentrate

    8.6 mg Sennosides Each

    Natural Vegetable Laxative Ingredient

    *Compare to Senokot®

    Product color may vary slightly due to nature of ingredients.

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

    100 TABLETS

    kjylued.jpg



    NDC 51645-851-10

    PlusPHARMA

    Senna

    Standardized Senna Concentrate

    8.6 mg Sennosides Each

    Natural Vegetable Laxative Ingredient

    *Compare to Senokot®

    Product color may vary slightly due to nature of ingredients.

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

    1000 TABLETS

    mjhleted.jpg

    NDC 51645-851-99

    PlusPHARMA

    Unit Dose

    Senna

    (Standardized Senna Concentrate)

    Sennosides 8.6 mg

    100 TABLETS (10x10)

    *Compare to the Active ingredient in Senokot®

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



    njuytled.jpg

  • INGREDIENTS AND APPEARANCE
    PLUS PHARMA SENNA  STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-851
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorbrownScore2 pieces
    ShapeROUND (Biconvex) Size9mm
    FlavorImprint Code GPI;W2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51645-851-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:51645-851-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:51645-851-9910 in 1 CARTON
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/27/2006
    Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270manufacture(51645-851)