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Sennosides (New World Imports, Inc)

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TABLET 100 TABLET in 1 BOTTLE (51824-217-01) Label Information

Complete Sennosides Information

  • ACTIVE INGREDIENT

    Sennosides


  • PURPOSE

    Laxative


  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.


  • INDICATIONS & USAGE

    For relief of occasional constipation and irregularity.

    This product produces a bowel movement in 6 to 12 hours.


  • WARNINGS

    Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

    Ask a doctor before use if you have a sudden change in bowel habits that persists over a period of 2 weeks.

    Ask a doctor or pharmacist before use if you are taking a prescription drug.  Laxatives may affect how other drugs work.  Take this product 2 or more hours before or after other drugs.

    When using this product do not use for longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative.  These could be signs of a serious condition.

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


  • DOSAGE & ADMINISTRATION

    Take preferably at bedtime or as directed by a doctor.  If you do not have comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.

    Adults and children over 12 years: 2 tablets once a day.  Maximum of 4 tablets twice a day.

    Children 6 to under 12 years: 1 tablet once a day.  Maximum of 2 tablets twice a day.

    Children 2 to under 6 years: 1/2 tablet once a day.  Maximum of 1 tablet twice a day.

    Children under 2: consult a doctor



  • INACTIVE INGREDIENT

    Colloidal silicon dioxide, croscarmellose sodium, dibasic dicalcium phosphate dihydrate, lactose, magnesium stearate, microcrystalline cellulose, and tartaric acid.


  • INGREDIENTS AND APPEARANCE
    SENNOSIDES 
    sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-217
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sennosides a and b (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) sennosides a and b 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    Colloidal silicon dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Magnesium stearate (UNII: 70097M6I30)  
    Cellulose, microcrystalline (UNII: OP1R32D61U)  
    Product Characteristics
    Color brown (Speckled various shades of brown) Score no score
    Shape ROUND (Round) Size 8mm
    Flavor Imprint Code AZ;217
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-217-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 09/10/2010
    Labeler - New World Imports, Inc (075372276)
    Establishment
    Name Address ID/FEI Business Operations
    Allegiant Health 079501930 manufacture(51824-217)