GADAVYT - magnesium citrate liquid 
Gadal Laboratories Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are
When using this product

Stop use and ask a doctor if

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

If pregnant or breast-feeding ask a health professional before use.

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

Other information

Inactive ingredients

citric acid, flavors, purified water, red 40, blue #1, saccharin sodium, sodium bicarbonate

Questions or comments?

(305) 382-3288

Gadal Laboratories Inc

Miami Fl 33186

magcitgrape

GADAVYT 
magnesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.6 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-102-10296 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33410/01/2012
Labeler - Gadal Laboratories Inc (841305639)

Revised: 10/2012
Document Id: 73057da3-ee31-4a5b-ba89-ca89b4d31895
Set id: 66551c1d-1e3e-4d69-b704-5419fcfc14c2
Version: 2
Effective Time: 20121015
 
Gadal Laboratories Inc