MAGNESIUM HYDROXIDE LIQUID [REBEL DISTRIBUTORS CORP]

MAGNESIUM HYDROXIDE LIQUID [REBEL DISTRIBUTORS CORP]
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NDC 21695-903-16
Set ID c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number PART331
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-903(NDC:0536-2470)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-903-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/22/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK

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