SUNMARK MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid

SUNMARK MILK OF MAGNESIA ORIGINAL by

Drug Labeling and Warnings

SUNMARK MILK OF MAGNESIA ORIGINAL by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tablespoonful)

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: 2 to 4 tablespoonfuls (TBSP)
• children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)
• children under 6 years: ask a doctor

Other information

each 15 mL tablespoon contains: magnesium 500 mg

store at room temperature and avoid freezing

close cap tightly after use

Inactive ingredients

purified water, sodium hypochlorite

package label

INGREDIENTS AND APPEARANCE

SUNMARK MILK OF MAGNESIA ORIGINAL 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-171
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: 49348-171-38	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/01/2012

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(49348-171) , relabel(49348-171)