MILK OF MAGNESIA- magnesium hydroxide suspension

MILK OF MAGNESIA by

Drug Labeling and Warnings

MILK OF MAGNESIA by is a Otc medication manufactured, distributed, or labeled by VALU MERCHANDISERS COMPANY, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet
• stomach pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

​ Ask a doctor or pharmacist before use if you are taking a prescription drug.

This product may interact with certain prescription drugs.

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 1 week

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

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Directions

• shake well before use
• 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: 30 mL to 60 mL
• children 6 to 11 years: 15 mL to 30 mL
• children under 6 years: ask a doctor

Other information

• each 15 mL contains: magnesium 500 mg, sodium 6 mg
• avoid freezing
• store at room temperature tightly closed

Inactive ingredients

carboxymethylcellulose sodium, citric acid, D & C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum

Questions or comments?

1-800-540-3765

package Label

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-648
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-648-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/01/2017

Labeler - VALU MERCHANDISERS COMPANY (868703513)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	pack(63941-648) , manufacture(63941-648)