MILK OF MAGNESIA- magnesium hydroxide liquid

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by Harris Teeter, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 15 mL Tablespoon)

Magnesium hydroxide USP 1200 mg

Purpose

Saline laxative

Use

relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ 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 (1-800-222-1222) 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
• do not use any other dosing device
• TBSP = Tablespoon, mL = milliliter

• age: dose
• adults and children 12 years and older: 30 mL (2 TBSP) to 60 mL (4 TBSP)
• children 6 to 11 years: 15 mL (1 TBSP) to 30 mL (2 TBSP)
• children under 6 years: ask a doctor

Other information

• each tablespoon (15 mL) contains : calcium 20 mg and magnesium 495 mg
• store at 20-25°C (68-77°F).  Avoid excessive heat above 40°C (104°F) and avoid freezing. Close cap tightly after use.

Inactive ingredients

flavor, purified water, saccharin sodium

Questions or comments?

1-855-274-4122

* This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Phillips’® Milk of Magnesia.

PROUDLY DISTRIBUTED BY:
HARRIS TEETER, LLC,
MATTHEWS, NC 28105

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

Harris TeeterTM
SALINE LAXATIVE
MILK OF MAGNESIA
Each 15 mL (1TBSP) dose of oral solution contains: 1200 mg magnesium hydroxide USP

• Stimulant Free
• Comfortable, Cramp-free Relief
• Sugar Free

Compare to the active ingredient in Phillips,® Milk of Magnesia*
Mint Flavor
TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
12 FL OZ
(355 mL)

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72036-005
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
PEPPERMINT (UNII: V95R5KMY2B)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	WHITE (White to off-white)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72036-005-16	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/28/2016

Labeler - Harris Teeter (047279351)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(72036-005)