Label: SENEXON- senna tablet, coated

  • 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 May 14, 2018

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) Sennosides 8.6mg

  • ASK DOCTOR/PHARMACIST

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

  • ASK DOCTOR

    Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

  • WARNINGS

    Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.

  • STOP USE

    Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product.  These may indicate a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    uses

    relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.

  • QUESTIONS

    1800 645-2158 9 am - 5 pm Monday - Friday

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol  oil

  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

    Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

    children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day

  • INDICATIONS & USAGE

    Relieves occasional constipation

    Generally produces bowel movement in 6-12 hours

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count8.6 mg
    10071610-058-65

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20180514JH

  • PRINCIPAL DISPLAY PANEL - 8.6 mg

    NDC 71610-058 - Sennosides (Senna) 8.6 mg
    Bottle Label 8.6 mg

  • INGREDIENTS AND APPEARANCE
    SENEXON 
    senna tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-058(NDC:0536-5904)
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    magnesium stearate (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    mineral oil (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-058-65100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/09/2006
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-058)
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