GADAVYT (MAGNESIUM CITRATE) LIQUID [GADAL LABORATORIES INC]

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GADAVYT (MAGNESIUM CITRATE) LIQUID [GADAL LABORATORIES INC]
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NDC 53113-101-10
Set ID 3b94301b-8f2c-41c7-b5b3-e0b53d69c2d3
Category HUMAN OTC DRUG LABEL
Packager Gadal Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART334
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  • 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, saccharin sodium, sodium bicarbonate

  • QUESTIONS

    Questions or comments?

    (305) 382-3288

    Gadal Laboratories Inc

    Miami Fl 33186

  • PRINCIPAL DISPLAY PANEL

    magcitcherry

  • INGREDIENTS AND APPEARANCE
    GADAVYT 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-101
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-101-10296 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)
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