Label: PROMOLAXIN- docusate sodium tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

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

  • Active ingredient

    Docusate Sodium 100 mg

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  • Purpose

    Stool Softener

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  • Uses

    • for relief of occasional constipation (irregularity). This product generally produces a bowel movement within 12 to 72 hours.
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  • 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
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  • Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks
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  • 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.

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  • If pregnant or breast-feeding,

    ask a doctor before use.

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  • Keep out of Reach of Children.

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

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  • 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.

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  • 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.
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  • Inactive ingredients

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

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  • 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

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  • Image of Label
  • INGREDIENTS AND APPEARANCE
    PROMOLAXIN 
    docusate sodium tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35356-822(NDC:27495-012)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    CROSCARMELLOSE SODIUM  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STARCH, CORN  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code GPI;S1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35356-822-60 60 in 1 BOTTLE
    2 NDC:35356-822-00 00 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 04/15/2011
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    Name Address ID/FEI Business Operations
    Lake Erie Medical DBA Quality Care Products LLC 831276758 repack(35356-822), relabel(35356-822)
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