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MILK OF MAGNESIA MINT

647 GC MOM MINT

Approved
Approval ID

f8bba8cb-a111-4285-8bdb-2273a049c3bb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

magnesium hydroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68788-8638
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
magnesium hydroxide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYPOCHLORITEInactive
Code: DY38VHM5OD
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MAGNESIUM HYDROXIDEActive
Quantity: 1200 mg in 15 mL
Code: NBZ3QY004S
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

package Label

Milk of Magnesia

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Saline laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

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 aretaking 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 right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

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  

adults and children 12 years and older

2 to 4 tablespoonfuls

children 6 to 11 years

1 to 2 tablespoonfuls

children under 6 years

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/12/2025

Other information

**each 15 mL tablespoonful contains:** magnesium 500 mg 

store at room temperature tightly closed

do not freeze

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8638-3

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

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