MILK OF MAGNESIA concentrate

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by West-Ward Pharmaceuticals Corp., Roxane Laboratories, Inc., West-Ward Columbus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CONCENTRATED Milk of Magnesia (Lemon Flavored)

Drug Facts

Serving Size: 10 mL (2 teaspoonful)
Active Ingredient (per 10 mL)	Purpose
Magnesium hydroxide 2400 mg	Laxative

Active Ingredient per 10 mL

Magnesium hydroxide 2400 mg

Purpose

Laxative

Keep Out of Reach of Children

Warnings

Ask a doctor before us if you have:

• Kidney disease
• Stomach pain, nausea or vomiting
• A magnesium restricted diet
• A sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if:

• You have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• You need to use a laxative for more than one week.

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

This package bears a tamper evident seal. If the seal is broken, do not use.

Suggested Uses

• Relieves occasional constipation (irregularity).

This product usually produces bowel movement in 1/2 to 6 hours.

Directions

• Shake well before use – Do not dilute.
• Do not exceed the maximum recommended daily dose in a 24 hour period.
• Dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor. Drink a full glass (8 oz.) of liquid with each dose.

• Adults and Children 12 Years and Older:

  10 to 20 mL (2 to 4 tsp.)

• Children 6 to 11 Years:

  5 to 10 mL (1 to 2 tsp.)

• Children under 6 Years:

  Ask a Doctor

Other Information

• 10 mL contains: magnesium 1000 mg
• 10 mL contains: sodium 21 mg

Storage and Handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Do not freeze, keep tightly closed.

Inactive Ingredients

Benzyl alcohol, carboxymethylcellulose sodium, citric acid anhydrous, glycerin, lemon oil, purified water, sodium citrate, sodium hexametaphosphate, sodium hyprochlorite, sorbitol, sucrose, vanillin.

Questions or Comments?

Call toll free 1-800-962-8364. You may also report serious side effects to this phone number

Distr. by: West-Ward
Pharmaceutical Corp.
Eatontown, NJ 07724

Revised August 2016

Package/Label Principal Display Panel

CONCENTRATED Milk of Magnesia (Lemon Flavored)

0054-3567-61: Bottles of 400 mL

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
milk of magnesia concentrate

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0054-3567
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
VANILLIN (UNII: CHI530446X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0054-3567-49	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2001
2	NDC: 0054-3567-61	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/12/2001

Labeler - West-Ward Pharmaceuticals Corp. (080189610)

Registrant - Roxane Laboratories, Inc. (833490464)

Establishment
Name	Address	ID/FEI	Business Operations
West-Ward Columbus Inc.		058839929	MANUFACTURE(0054-3567)