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Milk of Magnesia by Aurohealth LLC

Medically reviewed on January 25, 2018

Dosage form: liquid
Ingredients: MAGNESIUM HYDROXIDE 1200mg in 15mL
Labeler: Aurohealth LLC
NDC Code: 58602-323

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.

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.

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

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

AUROHEALTH
NDC 58602-323-16
*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

  • Stimulant Free
  • Comfortable, Cramp Free Relief
  • Sugar Free
TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

12 FL OZ
(355 mL)
Mint Flavor

MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-323
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT 
WATER 
SACCHARIN SODIUM 
Product Characteristics
ColorWHITE (White to off-white) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-323-16355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/28/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-323)

 
Aurohealth LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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