GADAVYT- magnesium citrate liquid

Gadavyt by

Drug Labeling and Warnings

Gadavyt 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 Ingredient                          Purpose
Magnesium citrate 1.745g per fl. Oz...... Saline Laxative

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
  

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
  

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

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, blue #1, saccharin sodium, sodium bicarbonate

QUESTIONS

Questions or comments?

(305) 382-3288

Gadal Laboratories Inc

Miami Fl 33186

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GADAVYT 
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CITRATE	1.745 g  in 29.6 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-103-10	296 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part334	10/01/2012

Labeler - Gadal Laboratories Inc (841305639)