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  5. Label Information: Pediatric Saline Laxative

FDA Label for Pediatric Saline Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH 59 ML DELIVERED DOSE)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DOSAGE WARNING
    7. ASK A DOCTOR OR PHARMACIST BEFORE USING IF THE CHILD
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF THE CHILD HAS
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 67 ML BOTTLE CARTON

Pediatric Saline Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Natureplex, Llc. 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.

Other



Drug Facts


Active Ingredients (In Each 59 Ml Delivered Dose)



Dibasic Sodium Phosphate 3.5g
Monobasic Sodium Phosphate 9.5g


Purpose



Saline laxative
Saline laxative


Use



Relieves occasional constipation


Warnings



For rectal use only


Dosage Warning



Using more than one enema in 24 hours can be harmful.


Ask A Doctor Or Pharmacist Before Using If The Child



  • has a sodium-restricted diet
  • has abdominal pain, nausea, or vomiting
  • has kidney disease, heart problems, or dehydration
  • has a sudden change in bowel habits that lasts over 2 weeks
  • already used a laxative for more than 1 week
  • is taking any other drug (take this product two or more hours before or after other drugs; laxatives may affect how other drugs work)

When Using This Product



  • do not use more than directed. Serious side effects may occur from excess dosage.
  • do not use for more than 3 days

Stop Use And Ask A Doctor If The Child Has



  • rectal bleeding
  • no bowel movement after use of a laxative
  • symptoms of dehydration such as thirst, dizzyness, or urinating less frequently than normal

    • These could be symptoms of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away: 800-222-1222.


Directions



Single daily dosage (per 24 hours)

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

children 2 to 11 years1 bottle once daily
children under 2 yearsask a doctor

Other Information



  • each 59 mL contains: sodium 2.2g
  • store at 15 to 30°C (59 to 86°F)
  • this product generally produces a bowel movement in 1 to 5 minutes

Inactive Ingredients



benzalkonium chloride, disodium EDTA, purified water


Questions Or Comments?



866-323-0107 or www.natureplex.com


Principal Display Panel - 67 Ml Bottle Carton



Natureplex™

pediatric
ages 2-11

NDC 67234-042-01

E
N
E
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A

*Compare
To
Fleet®

saline laxative

* Please review the disclaimer below.