MILK OF MAGNESIA- magnesium hydroxide liquid

MILK OF MAGNESIA by

Drug Labeling and Warnings

MILK OF MAGNESIA by is a Otc medication manufactured, distributed, or labeled by TOP CARE (TOPCO ASSOCIATES LLC), 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)
• usually 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

• age: dose
• adults and children 12 years and over: 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 tablespoonful contains: magnesium 500 mg
• avoid freezing
• store at room temperature tightly closed

Inactive ingredients

purified water, sodium hypochlorite

Questions or Comments?

1-800-540-3765

package label

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-649
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
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-649-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	12/01/2020

Labeler - TOP CARE (TOPCO ASSOCIATES LLC) (006935977)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(36800-649)