FDA Label for Gadavyt Enema
View Indications, Usage & Precautions
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 118 mL delivered dose)
Dibasic sodium phosphate 7 g............. Saline Laxative
Monobasic sodium phosphate 19 g......... Saline Laxative
Otc - 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
- do not use more than directed. Serious side effects may occur from excess dosage.
- do not use for more than 3 days
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 productOtc - 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.
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
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
Otc - Questions
Questions or comments?
305-382-3288
Package Label.Principal Display Panel
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