PHILLIPS ORIGINAL MILK OF MAGNESIA liquid

PHILLIPS ORIGINAL MILK OF MAGNESIA by

Drug Labeling and Warnings

PHILLIPS ORIGINAL 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) Purpose

Magnesium hydroxide 1200 mg...............…………..........Saline laxative

PURPOSE

Saline laxative

Use

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

WARNINGS

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

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 SAFETY INFORMATION

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 INGREDIENT

Inactive ingredients purified water, sodium hypochlorite

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHILLIPS ORIGINAL MILK OF MAGNESIA 
phillips original milk of magnesia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0030
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
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0030-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2014
2	NDC: 0280-0030-26	769 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2014
3	NDC: 0280-0030-04	1 in 1 CARTON	12/16/2014
3		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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)