Label: MILK OF MAGNESIA- milk of magnesia suspension

  • 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 January 9, 2018

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  • SPL UNCLASSIFIED SECTION

    ANTACID/SALINE LAXATIVE

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  • DESCRIPTION

    A suspension of magnesium hydroxide. Each 10 mL (2 teaspoonfuls) of Milk of Magnesia Concentrate is equivalent to 30 mL of Milk of Magnesia yielding 2400 mg of magnesium hydroxide and providing not less than 60 mq/10 mL of acid-neutralizing capacity (ANC).

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  • Inactive Ingredients

    A suspension of magnesium hydroxide. Each 10 mL (2 teaspoonfuls) of Milk of Magnesia Concentrate is equivalent to 30 mL of Milk of Magnesia yielding 2400 mg of magnesium hydroxide and providing not less than 60 mq/10 mL of acid-neutralizing capacity (ANC). Inactive Ingredients: Flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, silicone defoamer, sodium citrate, sodium saccharin, sodium salts of polymerized alkylnaphthalenesulfonic acid, sorbitol solution, and sucrose.

    Sodium Content: 19 mg/10 mL.

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  • FOR USE AS AN ANTACID

    INDICATIONS

    For the temporary relief of heartburn, upset stomach, sour stomach, and/or acid indigestion.

    DIRECTIONS

    Adults and children 12 years of age and over - Oral dosage is 5 mL (1 teaspoonful) with a little water up to four times daily or as directed by a physician. Children under 12 years of age - Consult a physician. SHAKE WELL BEFORE USING.

    WARNINGS

    The maximum recommended daily dosage of this product is 20 mL (4 teaspoonfuls). Do not take more than this dosage in a 24-hour period or use this dosage for more than 2 weeks unless directed by a physician. Do not use this product if you have kidney disease or if you are on a magnesium restricted diet unless directed by a physician. May have a laxative effect.

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  • FOR USE AS A LAXATIVE

    INDICATIONS

    For relief of occasional constipation. This product generally produces bowel movement in ½ to 6 hours.

    DIRECTIONS

    Drink a full glass (8 oz) of liquid following each dose. Adults and children 12 years of age and over - Oral dosage is 10 to 20 mL (2 to 4 teaspoonfuls); Children 6 to under 12 years of age - Oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls); Children 2 to under 6 years of age - Oral dosage is 5 mL (1 teaspoonful) or as directed by a physician. The dose may be taken as a single daily dose or in divided doses. Children under 2 years of age - Consult a physician. SHAKE WELL BEFORE USING.

    WARNINGS

    Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use longer than 1 week unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult your physician. Do not use this product if you have kidney disease or if you are on a magnesium restricted diet unless directed by a physician.

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  • WARNINGS

    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 immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    DRUG INTERACTION PRECAUTION

    Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

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  • HOW SUPPLIED

    Milk of Magnesia Concentrate (white suspension-lemon flavored) overbagged with 5 cups per bag, NDC 55154-9412-5.

    Repackaged By:

    Cardinal Health

    Zanesville, OH 43701

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  • STORAGE

    Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). PROTECT FROM FREEZING.

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  • SPL UNCLASSIFIED SECTION

    R04/14

    pai
    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    Repackaged By:

    Cardinal Health

    Zanesville, OH 43701

    L33755080815

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  • Principal Display Panel

    Milk of Magnesia Concentrate

    5 Cups

    bag label
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  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    milk of magnesia suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-9412(NDC:0121-0527)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 2400 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PYRROBUTAMINE NAPHTHALENE DISULFONATE (UNII: 144X0H6HW6)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-9412-5 5 in 1 BAG 06/07/2011
    1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 06/07/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-9412)
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