PHILLIPS FRESH MINT MILK OF MAGNESIA liquid

PHILLIPS FRESH MINT MILK OF MAGNESIA by

Drug Labeling and Warnings

PHILLIPS FRESH MINT MILK OF MAGNESIA by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 15 mL Tablespoon)

Magnesium hydroxide 1200 mg

PURPOSE

Saline laxative

INDICATIONS & USAGE

Use relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ to 6 hours.

WARNINGS

Warnings

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed the maximum recommended daily dose in a 24 hour period
• shake well before use
• 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.
• for accurate dosing, only use the dosing cup provided
• mL = milliliter

• 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 tablespoon (15 mL) contains: magnesium 500 mg

● store at room temperature. Avoid excessive heat above 40°C (104°F). Avoid freezing. Close cap tightly after use.

Inactive ingredients

flavor, mineral oil, purified water, saccharin sodium, sodium hypochlorite

QUESTIONS

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHILLIPS FRESH MINT MILK OF MAGNESIA 
phillips fresh mint milk of magnesia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0031
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0031-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2014
2	NDC: 0280-0031-26	769 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/16/2014

Labeler - Bayer HealthCare LLC. (112117283)