FDA Label for Gadavyt
View Indications, Usage & Precautions
Gadavyt 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 Ingredient PurposeMagnesium citrate 1.745g per fl. Oz...... Saline Laxative
Otc - Purpose
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 1/2 to 6 hours
Warnings
Warnings
Ask a doctor before use if you have
- kidney disease
- a magnesium restricted diet
- a sodium restricted diet
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that lasts more than 1 week. Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug When using this product
- do not exceed the maximum recommended daily dosage in a 24 hour period
Otc - Do Not Use
Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition
- you need to use a laxative for more than 1 week
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use.
Dosage & Administration
Directions
| adults and children 12 years of age and older | 1/2 to 1 bottle (10 fl. oz.) Drink a full 8 oz glass of liquid with each dose. These dose may be taken as a single daily dose or in divided doses |
| children 6 to under 12 years of age | 1/3 to 1/2 bottle with a fill 8 oz glass of liquid |
| children under 6 years of age | consult a doctor |
Indications & Usage
Other information
- each fluid once contains: sodium 36 mg, magnesium 199 mg
- store at room temperature
- protect from excessive heat and freezing
- discard unused product within 24 hours of opening
Inactive Ingredient
Inactive ingredients
citric acid, flavors, purified water, red 40, saccharin sodium, sodium bicarbonate
Otc - Questions
Questions or comments?
(305) 382-3288
Gadal Laboratories Inc
Miami Fl 33186
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