Drugplain

MILK OF MAGNESIA 1200 mg/15mL

magnesium hydroxide · SUSPENSION · VALU MERCHANDISERS COMPANY

8 Recalls on RecordCurrently in Shortage
Plain English

Milk of Magnesia is an over-the-counter oral suspension containing magnesium hydroxide that is used as a laxative to relieve constipation and as an antacid to treat heartburn and indigestion. The suspension is available in a strength of 1200 mg of magnesium hydroxide per 15 mL dose.

Key Facts

Brand Name
MILK OF MAGNESIA
Generic Name
magnesium hydroxide
NDC Code (Product)
63941-649
Manufacturer
VALU MERCHANDISERS COMPANY
Strength
1200 mg/15mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
07/01/2017

Recall History

8 Recalls on Record
Class I03/24/2022

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

CompletedVoluntary: Firm initiated
Class II06/07/2022

Plastikon Healthcare LLC

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

TerminatedVoluntary: Firm initiated
Class I06/07/2022

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products.

TerminatedVoluntary: Firm initiated
Class I08/30/2019

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

TerminatedVoluntary: Firm initiated
Class II03/24/2022

Plastikon Healthcare LLC

CGMP Deviations: Failure to properly investigate failed microbial testing.

CompletedVoluntary: Firm initiated
Class I06/07/2022

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II06/07/2022

Plastikon Healthcare LLC

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

constipation1,293 reports
chronic kidney disease1,006 reports
fall988 reports
pain975 reports
hypotension744 reports
acute kidney injury709 reports
nausea685 reports
balance disorder673 reports
cognitive disorder664 reports
drug ineffective663 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours

Dosage & Administration

Directions shake well before use do not exceed the maximum recommended daily dose in a 24 hour period 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 mL = milliliter age dose adults and children 12 years and over 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 years ask a doctor

Warnings

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 presently 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.

Frequently Asked Questions

What is MILK OF MAGNESIA used for?

Milk of Magnesia is an over-the-counter oral suspension containing magnesium hydroxide that is used as a laxative to relieve constipation and as an antacid to treat heartburn and indigestion. The suspension is available in a strength of 1200 mg of magnesium hydroxide per 15 mL dose.

Is MILK OF MAGNESIA a controlled substance?

MILK OF MAGNESIA is not classified as a controlled substance by the DEA.

What is the generic name for MILK OF MAGNESIA?

The generic name for MILK OF MAGNESIA is magnesium hydroxide. There are 10 other brand versions of magnesium hydroxide.

What is the NDC code for MILK OF MAGNESIA 1200 mg/15mL?

The NDC (National Drug Code) for MILK OF MAGNESIA 1200 mg/15mL is 63941-649, listed by VALU MERCHANDISERS COMPANY.