MILK OF MAGNESIA- milk of magnesia concentrate 
West-Ward Pharmaceuticals Corp.

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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Drug Facts

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

fpl-label-400ml-07.jpg

CONCENTRATED Milk of Magnesia (Lemon Flavored)

0054-3567-61: Bottles of 400 mL

MILK OF MAGNESIA 
milk of magnesia concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0054-3567
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0054-3567-49100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2001
2NDC:0054-3567-61400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/12/2001
Labeler - West-Ward Pharmaceuticals Corp. (080189610)
Registrant - Roxane Laboratories, Inc. (833490464)
Establishment
NameAddressID/FEIBusiness Operations
West-Ward Columbus Inc.058839929MANUFACTURE(0054-3567)

Revised: 5/2015
Document Id: 20be85d3-6239-42d4-a785-bcf098acb2cf
Set id: d94ebb8a-2576-4fb5-8712-584166f88949
Version: 3
Effective Time: 20150508
 
West-Ward Pharmaceuticals Corp.