MILK OF MAGNESIA - magnesium hydroxide liquid 
Aurohealth LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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

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

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

Inactive ingredients

purified water

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 58602-322-16
*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

TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
12 FL OZ
(355 mL)
Original Flavor
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL) Bottle

MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-322-16355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/28/201609/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/28/201609/01/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-322)

Revised: 11/2020
Document Id: 5b9cf0be-fe9b-4105-aa6d-ec99c9f7fd93
Set id: 7f7f66eb-71b6-4002-84c8-48d687044664
Version: 3
Effective Time: 20201116
 
Aurohealth LLC