Label: PROMOLAXIN- docusate sodium 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 January 29, 2014

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  • 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 and children 12 years of age and older:

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

    Children under 12 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

    Repackaged By:
    Aidarex Pharmaceuticals, LLC.
    Corona, CA 92880

  • Package/Label Principal Display Panel

    NDC 33261-0796-00

    Promolaxin™

    Docusate Sodium

    Stool Softener

    100 mg Each

    100 Tablets

    IMAGE LABEL

  • INGREDIENTS AND APPEARANCE
    PROMOLAXIN 
    docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-796(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)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (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:33261-796-00100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33404/15/2011
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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