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 118 mL delivered dose)

Dibasic sodium phosphate 7 g............. Saline Laxative

Monobasic sodium phosphate 19 g......... Saline Laxative

PURPOSE

Uses

• relieves 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 use if you have

• a sodium-restricted diet
• abdominal pain, nausea or vomiting
• kidney disease, heart problems, or are dehydrated
• noticed a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use if you are

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

DO NOT USE

Stop use and ask a doctor if

• you have rectal bleeding
• you have no bowel movement after use of a laxative

These could be signs of 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

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

• adults and children 12 years and over: one bottle once daily
• children 2 to under 12 years: 1/2 bottle once daily
• children under 2 years: do not use

INDICATIONS & USAGE

Other information

• each 118 mL contains: sodium 4.3 g
• store at room temperature 20-25 degrees C (68 -77 degrees F)
• 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: 53113-104
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	7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC	19 g  in 118 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: 53113-104-45	133 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)