MILK OF MAGNESIA- milk of magnesia suspension
Cardinal Health

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.

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MILK OF MAGNESIA
CONCENTRATE

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.

Repackaged By:

Cardinal Health

Zanesville, OH 43701

STORAGE

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

R04/14

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L33755080815

Principal Display Panel

Milk of Magnesia Concentrate

5 Cups

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 (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-9412)

Revised: 1/2018
Document Id: 9d965e32-b78d-4294-b244-fa56251e75fd
Set id: 04e7f807-8d79-4836-8efa-d874cbf4d2e2
Version: 5
Effective Time: 20180109
Cardinal Health