GADAVYT ENEMA- dibasic sodium phosphate, monobasic sodium phosphate liquid

Gadavyt Enema by

Drug Labeling and Warnings

Gadavyt Enema by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

Uses

for 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
  

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

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

QUESTIONS

Questions or comments?

305-382-3288

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GADAVYT ENEMA 
dibasic sodium phosphate, monobasic sodium phosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-105
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC	3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC	9.5 g  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-105-66	66 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2012

Labeler - Gadal Laboratories Inc (841305639)