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  5. Label Information: Fleet

FDA Label for Fleet

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 118-ML DELIVERED DOSE)
    2. USE
    3. WARNINGS
    4. ASK A DOCTOR BEFORE USING THIS PRODUCT IF YOU
    5. STOP USE AND ASK A DOCTOR IF YOU HAVE
    6. IF PREGNANT OR BREAST-FEEDING
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABEL.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 118-Ml Delivered Dose)



Monobasic Sodium Phosphate 19 g, Saline Laxative
Dibasic Sodium Phosphate 7 g, Saline Laxative


Use



For relief of occasional constipation


Warnings



For rectal use only.

Dosage warning:

Using more than one enema in 24 hours can be harmful. Do not use without asking a doctor:

  • for more than 3 days
  • if you have kidney disease
  • if you have heart problems
  • if you are dehydrated

Ask A Doctor Before Using This Product If You



  • are 55 years or older
  • are on a sodium-restricted diet

    • Ask a doctor before using any laxative if you have

    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

Stop Use And Ask A Doctor If You Have



  • rectal bleeding
  • no bowel movement or no liquid comes out of the rectum after 30 minutes
  • symptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal)

    • These symptoms may indicate a serious condition


If Pregnant Or Breast-Feeding



Ask a health professional before use.


Keep Out Of Reach Of Children



Keep out of reach of children to prevent accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Single Daily Dosage (per 24 hours).

Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphates product.

 adults and children 12 years and over 1 bottle per day
 children 2 to 11 years Use Fleet Pedia-Lax Enema
 children under 2 years DO NOT USE


Other Information



  • each 118-mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while taking this product
  • this product generally produces a bowel movement in 1-5 minutes
  • BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE.
  • for complete professional use warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients



benzalkonium chloride, disodium EDTA, purified water


Questions?



1-866-255-6960 or www.fleetlabs.com


Package Label.Principal Display Panel



Fleet Enema Six Pack Carton - EnemaSixPackCarton

Fleet Enema Six Pack Carton - EnemaSixPackCarton


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