MILK OF MAGNESIA MINT- magnesium hydroxide liquid
MAJOR Pharmaceuticals Inc.

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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MAOR MOM mnt

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

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
store at room temperature and avoid freezing
close cap tightly after use

Inactive ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

Questions or comments?

800-616-2471

package Label

NDC 0904-0789-14

MAJOR
Milk of Magnesia

Saline Laxative

MINT FLAVOR
effective overnight relief

cramp free

stimulant free

sugar free

compare to the active ingredient of Phillips' milk of magnesia

12 FL OZ (355 mL)

maj

MILK OF MAGNESIA MINT
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-0789
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-0789-14	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/06/2011	08/01/2020

Labeler - MAJOR Pharmaceuticals Inc. (191427277)

Registrant - GCP Laboratories (965480861)

Name	Address	ID/FEI	Business Operations
Establishment
GCP Laboratories		965480861	manufacture(0904-0789)

Revised: 12/2021

Document Id: d3ad25a5-1296-f34b-e053-2995a90ab676

Set id: 42d7e2d7-27b4-430c-851a-f2a2377e8a87

Version: 3

Effective Time: 20211221

MAJOR Pharmaceuticals Inc.