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  5. Label Information: Fleet

FDA Label for Fleet

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL

Fleet Product Label

The following document was submitted to the FDA by the labeler of this product C.b. Fleet Company, 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.

Active Ingredient (In Each Softgel)



Docusate sodium 100 mg


Purpose



Stool softener


Uses



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

Do Not Use



  • if you are presently taking mineral oil, unless directed by a doctor

Ask A Doctor Before Use If You Have



  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts 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 symptoms may indicate a serious condition.
  • you need to use a stool softener laxative for more than 1 week

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions



  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    • Adults and children 12 years and overtake 1-3 softgels daily
    Children 2 to under 12 years of agetake 1 softgel daily
    Children under 2 yearsask a doctor

Other Information



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

Inactive Ingredients



black edible ink, citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol solution, water


Questions?



Call 1-866-255-6960


Principal Display Panel



Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

Principal Display Panel FleetDocusate sodium 100 mg Stool SoftenerOral Laxative25 softgels - fleet oral lax docusate sodium 0132 0402 01

Principal Display Panel FleetDocusate sodium 100 mg Stool SoftenerOral Laxative25 softgels - fleet oral lax docusate sodium 0132 0402 01


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