Label: LAXACIN tablet

  • 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 26, 2018

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

  • ACTIVE INGREDIENT

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Stool Softener

    Laxative

  • INDICATIONS & USAGE


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

  • WARNINGS

    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 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.

  • OVERDOSAGE

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

  • DOSAGE & ADMINISTRATION

    take preferably at bedtime or as directly 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

    Other information

    Each tablet contains: Calcium 20 mg
    Each tablet contains: Sodium 4 mg
    Store at room temperature
    Keep lid tightly closed in a dry place
    Do not use if imprinted safety seal under cap is broken or missing

  • DO NOT USE

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

    Drug Facts

  • DO NOT USE

    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

  • ASK DOCTOR


    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.

  • 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

    ther information


    each tablet contains: calcium 20 mg, sodium 4 mg

    keep lid tightly closed

    store at room temperature in a dry place

  • INACTIVE INGREDIENT


    nactive 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


    uestions? 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 9006

  • 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.

  • PRINCIPAL DISPLAY PANEL

    497

  • PRINCIPAL DISPLAY PANEL


    [Laxacin 10-18]

  • INGREDIENTS AND APPEARANCE
    LAXACIN 
    laxacin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-497(NDC:50488-0901)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-497-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/26/2018
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-497)