MILK OF MAGNESIA suspension

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ANTACID/SALINE LAXATIVE

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).

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.

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.

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.

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

Distributed by:

Cardinal Health

Dublin, OH 43017

L33755080318

STORAGE

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

SPL UNCLASSIFIED SECTION

R04/14

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed by:

Cardinal Health

Dublin, OH 43017

L33755080318

Principal Display Panel

Milk of Magnesia Concentrate

5 Cups

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 (603638201)