MILK OF MAGNESIA MINT- magnesium hydroxide liquid

MILK OF MAGNESIA MINT by

Drug Labeling and Warnings

MILK OF MAGNESIA MINT by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, 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, 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

package Label

compare to active ingredient in phillips' milk of magnesia

Rugby

NDC: 0536-2470-83
mint flavor

Milk of Magnesia

Saline Laxative

Net Contents
12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA MINT 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-2470
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-2470-83	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017
2	NDC: 0536-2470-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/28/2011

Labeler - Rugby Laboratories (079246066)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(0536-2470)