Label: GADAVYT- magnesium citrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 15, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    magcitgrape

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!