Milk of Magnesia

Cardinal Health

Milk of Magnesia Concentrate

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Keep Out of Reach of Children
• Milk of Magnesia Uses
• Warnings
• Directions
• Inactive ingredients
• Storage
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Antacid, Saline Laxative

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.

Milk of Magnesia Uses

For use as an antacid:

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

For use as a laxative:

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

Warnings

For use as an antacid

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.

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.

Directions

For use as an Antacid:

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.

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 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.

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

How Supplied:

Milk of Magnesia Concentrate (white suspension-lemon flavored) is supplied in the following oral dosage form: NDC 0121-0527-10 (unit dose cups of 10 mL, 10 x 10's).

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

Principal Display Panel

Milk of Magnesia

Concentrate

5 cups