PHILLIPS MILK OF MAGNESIA CONCENTRATED FRESH STRAWBERRY liquid

Phillips Milk of Magnesia Concentrated by

Drug Labeling and Warnings

Phillips Milk of Magnesia Concentrated 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 2400 mg: Saline laxative

PURPOSE

Saline laxative

Use

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

WARNINGS

Warnings

DO NOT USE

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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 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 glas (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: 15 mL to 30 mL
• Children under 12 years: ask a doctor

Other information

• each 15 mL contains: magnesium 1000 mg
• store at room temperature. Avoid freezing. Close cap tightly after use.

Inactive ingredients

anhydrous citric acid, D&C red #28, flavors, glycerin, propylene glycol, purified water, sodium hypochlorite, sorbitol, sucrose

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHILLIPS MILK OF MAGNESIA CONCENTRATED  FRESH STRAWBERRY
phillips milk of magnesia concentrated fresh strawberry liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0033
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	2400 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0033-08	1 in 1 CARTON	12/18/2014
1		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0280-0033-09	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/18/2014

Labeler - Bayer HealthCare LLC. (112117283)