Label: PROMOLAXIN- docusate sodium tablet

  • NDC Code(s): 27495-012-01
  • Packager: Physicians Science & Nature Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2024

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

  • Active ingredient

    Docusate Sodium 100 mg

  • Purpose

    Stool Softener

  • Uses

    • for relief of occasional constipation (irregularity). This product generally produces a bowel movement within 12 to 72 hours.
  • Warnings

  • Do not use

    • laxative products for longer than one week unless directed to do so by a doctor
    • if you are presently taking mineral oil unless told to do so by a doctor
  • Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks
  • Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

      These could be signs of a serious condition.

  • If pregnant or breast-feeding,

    ask a doctor before use.

  • Keep out of Reach of Children.

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

  • Directions

    Adults andchildren 12 yearsof age and older:

    Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor.

    Children under12 years of age:

    Consult a doctor before use.

  • Other information

    • Each tablet contains: Calcium 40 mg
    • Each tablet contains: Sodium 10 mg
    • Store at room temperature.
    • Do not use if imprinted safety seal is broken or missing.
  • Inactive ingredients

    Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

  • Questions?

    If you have any questions or comments, or to report an adverse event,

    please contact 714-875-6316.

    Manufactured for:Physician's Science and Nature, Inc.

    220 Newport Center Drive 11-634, Newport Beach, CA 92660

  • Package/Label Principal Display Panel

    Physician's Science and Nature, Inc.

    NDC 27495-012-01

    Promolaxin™

    Docusate Sodium

    Stool Softener

    100 mg Each

    100 Tablets

    Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROMOLAXIN 
    docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27495-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code GPI;S1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27495-012-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/15/2011
    Labeler - Physicians Science & Nature Inc. (012485755)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gemini Pharmaceuticals055942270manufacture(27495-012)