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  5. Label Information: Ready-to-use Enema

FDA Label for Ready-to-use Enema

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 118 ML DELIVERED DOSE)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USING THIS PRODUCT IF YOU:
    6. ASK A DOCTOR BEFORE USING ANY LAXATIVE IF YOU HAVE:
    7. STOP USE AND ASK A DOCTOR IF YOU HAVE:
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN
    10. WHEN USING THIS PRODUCT, DO NOT USE MORE THAN DIRECTED.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Ready-to-use Enema Product Label

The following document was submitted to the FDA by the labeler of this product Target Corporation. 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)



Sodium Phosphate 19 g

Dibasic Sodium Phosphate 7 g


Purpose



saline laxative & bowel cleanser


Use



 for relief of occasional constipation or bowel cleansing before rectal examinations


Warnings



For rectal use only

Dosage warning: Using more than one enema in 24 hours can be harmful


Ask A Doctor Before Using This Product If You:



  • Are on a sodium-restricted diet
  • Have kidney disease

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 after the enema is given

    • These symptoms may indicate a serious condition


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children



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


When Using This Product, Do Not Use More Than Directed.



Serious side effects may occur from excess dosage.


Directions



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

adults & children 12 years and older1 Bottle
children under 12 yearsAsk your child's pediatrician
children under 2 yearsDO NOT USE

Other Information



  • Each 118 mL contains: sodium 4.4 g
  • This product generally results in a bowel movement in 1 to 5 minutes
  • Tamper Evident: If the bottle is open do not use
  • Consult PHYSICIAN DESK REFERENCE® for complete professional labeling.

Inactive Ingredients



Benzalkonium chloride, disodium EDTA and purified water


Questions Or Comments?



Call 1-877-545-3635


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