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  5. Label Information: Gadavyt Enema

FDA Label for Gadavyt Enema

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INDICATIONS & USAGE
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gadavyt Enema Product Label

The following document was submitted to the FDA by the labeler of this product Gadal Laboratories 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.

Otc - Active Ingredient



Active ingredients (in each 59 mL delivered dose)

Dibasic sodium phosphate 3.5 g............. Saline Laxative

Monobasic sodium phosphate 9.5 g......... Saline Laxative


Otc - Purpose



Usesfor relief of occasional constipation

Warnings



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 the child
  • is on a sodium-restricted diet
  • has kidney disease
    • Ask a doctor before using any laxative if the child has
    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits that lasting more than 2 weeks
    • already used a laxative for more than 1 week


Otc - Do Not Use



Stop use and ask a doctor if the child has
  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)
    • These symptoms may indicate a serious condition

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding,

ask a health professional before use.


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. (1-800-222-1222)


Dosage & Administration



Directions

Single Daily Dosage

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

Do not use if child is taking another sodium phosphates product.

children 5 to 11
one bottle as directed by a doctor
children 2 to under 5 years
one-half bottle (see below)
children under 2 years
DO NOT USE
One-half bottle preparation:Unscrew cap and remove 2 table spoons of liquid with a measuring spoon. Replace cap and follow directions below.

Indications & Usage



Other information
  • each 59 mL delivered dose contains: sodium 2.2 g
  • additional liquids by mouth are recommended while taking this product
  • this product generally produces bowel movement in 1 to 5 minutes

Inactive Ingredient



Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water


Otc - Questions



Questions or comments?

305-382-3288


Package Label.Principal Display Panel



enemakids - enemakids

enemakids - enemakids


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