Label: MAGNESIUM HYDROXIDE- magnesium hydroxide 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 February 21, 2011

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

  • Active ingredient

    Magnesium Hydroxide 400mg

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  • Purpose

    Saline Laxative / Antacid

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  • Keep Out of Reach of Children

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

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  • Uses

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

    Antacid: relieves heartburn, sour stomach & acid indigestion.

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  • 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.

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  • Other Information

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

    store at room temperature

    protect from freezing

    keep tightly closed

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  • 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

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  • Inactive ingredients

    flavor, purified water, saccharin sodium, sodium hypochlorite

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

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  • Package/Label Principal Display Panel
  • 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
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