FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Purpose
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).
Flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, silicone defoamer, sodium saccharin, and sorbitol solution.
For the temporary relief of heartburn, upset stomach, sour stomach, and/or acid indigestion.
For relief of occasional constipation. This product generally produces bowel movement in ½ to 6 hours.
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.
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.
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.
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.
Otc - 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.
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.
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 × 10's).
Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). PROTECT FROM FREEZING.
Principal Display Panel - 30 Ml Cup Label
Delivers 30 mL
MILK OF MAGNESIA
Each 30 mL contains:
Magnesium Hydroxide 2400 mg.
Antacid, Saline Laxative
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
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