MAGNESIUM CITRATE LIQUID [P & L DEVELOPMENT, LLC]

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MAGNESIUM CITRATE LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0326-1
Set ID 4b36771f-094b-4de9-8ddf-77a92078319d
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient

    Magnesium citrate 1.745g per fl. oz.

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours
  • Warnings

    Do not use

    laxative products for longer than 1 week unless directed by a doctor. 

    Ask a doctor before use if you have

    • kidney disease
    • a megnesium 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 doctot 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. 

    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.

    If pregnant or breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

    In case of ovedose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

  • Directions

    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose or in divided doses
    adults and children 12 years of age and over1/2 bottle to 1 bottle (10 fl oz) 
    children 6 to 11 years of age 1/3 bottle to 1/2 bottle 
    children under 6 years of age consult a doctor 

  • Other information

    • each fluid ounce contains: magnesium 280 mg, sodium 37 mg
    • store between 46-86ºF (8-30ºC). Do not refrigerate.
    • protect from excessive heat and freezing
    • discard unused product within 24 hours of opening bottle
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavors, purified water, saccharin sodium anhydruos, sodium bicarbonate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    magnesium citrate

    Saline Laxative

    sugar-free

    oral solution

    Cherry Flavor

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

    Manufactured by:

     PL Developments

    200 Hicks Street

    Westbury, NY 11590                           

  • Package Label

    Magnesium Citrate 1.745g

    READYinCASE Magnesium Citrate

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0326
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0326-1296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/31/2015
    Labeler - P & L Development, LLC (101896231)
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