Label: SENNA-LAX- sennosides tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

    Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses

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

    Do not use

    • laxative products for longer than one week unless directed by a doctor

    Do not use

    laxative products for longer than one 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 care 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

    • Adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
    • Children 6 to under 12 yearsof age: 1 tablet once a day: maximum 2 tablets once a day
    • Children 2 to under 6 yearsof age ½ tablet once a day: maximum 1 tablet once a day
    • Children under 2 years of age: ask a doctor

  • Other information

    • Each tablet contains: Calcium 20 mg
    • Store at room temperature
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil and polyethylene glycol

  • Questions or comments?

    (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    Tamper Evident:

    Do not use if sealed blister units are broken or damaged.

    Product color may slightly vary

    due to natural changes of ingredients.

    Distributed by:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    M-29 Rev. 04/17 Re-Order No. 700532

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SENNA-LAX 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-629(NDC:0904-6522)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 1122;1122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55700-629-1010 in 1 CARTON05/25/201811/30/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/25/201811/30/2025
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lake Erie Medical DBA Quality Care Products LLC831276758relabel(55700-629)
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