NDC | 53113-104-45 |
Set ID | 8d47021a-c973-4a25-acc3-98e3001ec8db |
Category | HUMAN OTC DRUG LABEL |
Packager | Gadal Laboratories Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART334 |
- ACTIVE INGREDIENT
- PURPOSE
-
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
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GADAVYT ENEMA
dibasic sodium phosphate, monobasic sodium phosphate liquidProduct 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)