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Milk of Magnesia by Pharmaceutical Associates, Inc.

Medically reviewed on September 25, 2017

Dosage form: suspension
Ingredients: Magnesium Hydroxide 400mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0431

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.

Milk of Magnesia

ANTACID/SALINE
LAXATIVE

DESCRIPTION

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).

Inactive Ingredients

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

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 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.

WARNINGS

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

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 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.

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.

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.

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 × 10's).

STORAGE

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

R04/14

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 30 mL Cup Label

Delivers 30 mL
NDC 0121-0431-30

MILK OF MAGNESIA
USP

Each 30 mL contains:
Magnesium Hydroxide 2400 mg.
Antacid, Saline Laxative

SHAKE WELL

FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0431
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Magnesium Hydroxide (MAGNESIUM CATION and HYDROXIDE ION) Magnesium Hydroxide400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (4000 MPA.S) 
METHYLPARABEN 
POTASSIUM CITRATE 
PROPYLENE GLYCOL 
WATER 
CYCLOMETHICONE 4 
Propylparaben 
SORBITOL 
SACCHARIN SODIUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0431-3010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
130 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33109/04/1979
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693MANUFACTURE(0121-0431)

 
Pharmaceutical Associates, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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