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 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, magnesium 500 mg, and sodium 1.43 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

D&C Red No. 28, flavor, glycerin, purified water, saccharin sodium, xanthan gum.

Questions or comments?

1-855-274-4122

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

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

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

AUROHEALTH
NDC: 58602-321-16
*Compare to the active ingredient
in Phillips’® Milk of Magnesia
Milk of
Magnesia
Saline Laxative
Each 15 mL (1TBSP) dose of
oral solution contains:
1200 mg - Magnesium hydroxide USP

• Very low sodium
• Sugar Free
• Stimulant Free
• Comfortable, Cramp Free Relief

    Contains: Less than 0.5% alcohol

TAMPER-EVIDENT: Do not use
if imprinted neckband is missing or broken.

Cherry Flavor          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: 58602-321
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
CHERRY (UNII: BUC5I9595W)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (Pink to Light Pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-321-16	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2016
2	NDC: 58602-321-32	769 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 - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-321)