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  5. Label Information: Colace

FDA Label for Colace

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS COLACE 100 MG ACTIVE INGREDIENT (IN EACH CAPSULE)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. OTHER

Colace Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts Colace 100 Mg Active Ingredient (In Each Capsule)



Docusate sodium 100 mg


Purpose



Stool softener


Uses



  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours

Do Not Use



  • 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 movements that continues over a period of 2 weeks

Other Information



  • each tablet contains: sodium 5 mg
    VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    • Keep tightly closed.


Inactive Ingredients



D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide


Other



Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146


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