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Laxacin (Alexso Inc)

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TABLET 100 TABLET in 1 BOTTLE (50488-0901-1) Label Information

Complete Laxacin Information

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg


  • PURPOSE

    Purposes

    Stool softener

    Laxative


  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings


  • DO NOT USE

    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 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

    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.


  • PREGNANCY OR BREAST FEEDING

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


  • 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.


  • 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


  • STORAGE AND HANDLING

    Other information

    • each tablet contains: calcium 20 mg, sodium 4 mg
    • keep lid tightly closed
    • store at room temperature in a dry place

  • 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.


  • QUESTIONS

    Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078


  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Alexso Inc.

    Los Angeles, CA 90064


  • PRINCIPAL DISPLAY PANEL

    NDC: 50488-0901-1

    Laxacin

    (laxastimucin)

    Laxative Plus Stool Softener

    Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each

    Fast Dependable Relief

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

    100 Tablets

    Laxacin 10-18


  • INGREDIENTS AND APPEARANCE
    LAXACIN 
    docusate sodium and sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-0901
    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 A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code G55
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50488-0901-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 10/15/2018
    Labeler - Alexso Inc (070822737)