Label: SENNA TABS- senna 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 January 11, 2021

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  • Active ingredient (in each tablet)

    Sennosides 8.6mg

  • 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 the 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

    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

    ½ tablet once a day

    1 tablet twice a day

    Children under 2 years

    Ask a doctor

    Ask a doctor

  • Other information

    • each tablet contains 31 mg of calcium, 2 mg of sodium, Very Low Sodium
    • store at room temperature between 150-300C (590-860F)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, talc and triacetin

  • Questions or comments?

    (866) 562-2756 Mon - Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-363-11

    manufactured in the USA

    *Compare to the active ingredient of Senokot®

    Senna-Tabs

    Natural Vegetable Laxative Ingredient

    1000 TABLETS

    8.6 mg each

    Senna 8.6mg tablet Product Label

  • INGREDIENTS AND APPEARANCE
    SENNA TABS 
    senna tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-363
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-363-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2018
    2NDC:16103-363-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/03/2018
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc557054835analysis(16103-363) , manufacture(16103-363) , pack(16103-363) , label(16103-363)
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