MILK OF MAGNESIA- magnesium hydroxide suspension

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient per 30mL (1 Unit Dose)

Magnesium hydroxide 2,400 mg

Purpose

Saline laxative

Uses

   relieves occasional constipation (irregularity)

   usually produces bowel movement in ½ hour to 6 hours

Warnings

Ask a doctor before use if you have  Kidney disease a magnesium-restricted diet Stomach pain 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 may 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 accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 (8oz) of liquid with each dose

• age: dose
• Adults and children over 12 years of age: Take 30mL (one unit dose) to 60mL (2 unit dose)
• Children under 12 years of age: Ask a doctor

Other information

   each 30 mL (unit dose) contains​ Magnesium 1000 mg

   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

   protect from freezing

   do not use if lid is torn or broken

INACTIVE INGREDIENT

Inactive ingredients purified water, and sodium hypochlorite.

NDC Information -

2400 mg/30 mL

Each 30 mL of Milk of Magnesia contains Magnesium hydroxide 2,400mg and is supplied in the following oral dosage forms:

NDC: 57237-314-03 unit dose cup 30mL
NDC: 57237-314-31 (100x30) unit dose cups 30mL

QUESTIONS

Questions or comments?Call 1-844-474-7464

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Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

FG-37/Iss.: 04/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2400 mg/30 mL

Lid Label NDC: 57237-314-03

2400 mg/30 mL

Case Label NDC: 57237-314-31

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-314
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	2400 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-314-31	100 in 1 BOX, UNIT-DOSE	07/05/2023
1	NDC: 57237-314-03	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007.58	07/05/2023

Labeler - Rising Pharma Holdings, Inc. (116880195)