Label: MILK OF MAGNESIA- magnesium hydroxide suspension 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/11

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  • Active ingredient

    A suspension of magnesium hydroxide. Each 5 ml (1 teaspoonful) contains: 400 mg of magnesium hydroxide and provides not less than 10 mEq/5 mL of acid-neutralizing capacity (ANC)

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  • Purpose

    Antacid, Saline Laxative

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  • Keep Out of Reach of Children

    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.

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  • Uses

    For use as an Antacid:

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

    For use as a Laxative:

    For relief of occasional constipation. This product generally produces bowel movement in 1/2 to 6 hours.

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  • Warnings

    For use as an Antacid:

    The maximum recommended daily dosage of this product is 60 mL (12 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.

    For use as a Laxative:

    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.

    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.

    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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  • Directions

    For use as an Antacid:

    Adults and children 12 years of age and over - Oral dosage is 5 to 15 mL (1 to 3 teaspoonfuls) 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.

    For use as a Laxative:

    Drink a full glass (8 oz) of liquid following each dose. Adults and children 12 years of age and over - Oral dosage is 30 to 60 mL (2 to 4 tablespoonfuls); Children 6 to under 12 years of age - Oral dosage is 15 to 30 mL (1 to 2 tablespoonfuls); Children 2 to under 6 years of age - Oral dosage is 5 to 15 mL (1 to 3 teaspoonfuls) 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.

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  • Inactive ingredients

    Flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, silicone defoamer, sodium saccharin, and sorbitol solution

    How Supplied

    Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form: NDC 0121-0431-30 (unit dose cups of 30 mL, 10 x 10's).

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  • Storage

    Keep tightly closed. Store at Controlled Room Temperature, 20-25 C (68-77 F). PROTECT FROM FREEZING.

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    R05/02

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  • Principal Display Panel

    Milk of Magnesia USP

    5 Unit Dose Cups

    bag label
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  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    milk of magnesia suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-9403(NDC:0121-0431)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    METHYLPARABEN  
    POTASSIUM CITRATE  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SACCHARIN SODIUM  
    SORBITOL  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-9403-5 5 in 1 BAG
    1 30 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/07/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK
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