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Magnesium Hydroxide (Rebel Distributors Corp)

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LIQUID 473 mL in 1 BOTTLE (21695-903-16) Label Information

Complete Magnesium Hydroxide Information

  • Active ingredient

    Magnesium Hydroxide 400mg


  • Purpose

    Saline Laxative / Antacid


  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away.


  • Uses

    Laxative: relieves occasional constipation; generally produces a bowel movement in 1/2 to 6 hours.

    Antacid: relieves heartburn, sour stomach & acid indigestion.


  • Warnings

    Ask a doctor before use if you have:

    ° kidney disease ° a magnesium-restricted diet ° stomach pain, nausea or vomiting ° a sudden change in bowel habits that lasts over 2 weeks

    Ask a doctor or pharmacist before use if you are taking any other drug.

    ° antacids may interact with certain prescription drugs ° laxatives may affect how other drugs work, so should be taken 2 or more hours before or after other drugs.

    When using this product as an antacid, it may have a laxative effect.

    Stop use and ask a doctor if ° you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition ° You need to use a laxative for more than 1 week ° symptoms last more than 2 weeks.

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


  • Other Information

    each 5 mL teaspoon contains: magnesium 165mg and sodium 2 mg

    store at room temperature

    protect from freezing

    keep tightly closed


  • Directions

    Laxative: ° shake well before using

    ° drink a full glass (8 ounces) of liquid with each dose

    ° may be taken as a single or divided dose

    Antacid: ° do not take more than 12 teaspoons in 24 hours

    ° do not use maximum dosage for more than 2 weeks

    Laxative:

    adults and children 12 years and older: 2 to 4 tablespoons

    children 6 to under 12 years: 1 to 2 tablespoons

    children 2 to under 6 years: 1 to 3 teaspoons

    children under 2 years: ask a doctor

    Antacid:

    adults and children 12 years and older: 1 to 3 teaspoons with water, up to 4 times daily

    children under 12 years: ask a doctor


  • Inactive ingredients

    flavor, purified water, saccharin sodium, sodium hypochlorite

    Questions or comments? Call 1-800-645-2158, 9 am - 5 pm EST, Monday-Friday


  • Package/Label Principal Display Panel

    Milk of Magnesia


  • INGREDIENTS AND APPEARANCE
    MAGNESIUM HYDROXIDE 
    magnesium hydroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-903(NDC:0536-2470)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE 400 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-903-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 03/22/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK