MILK OF MAGNESIA- magnesium hydroxide suspension 
Rising Pharma Holdings, Inc.

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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Milk of Magnesia 2400 mg/30 mL

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

 agedose
Adults and children over 12 years of ageTake 30mL (one unit dose) to 60mL (2 unit dose)
Children under 12 years of ageAsk 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 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 or comments?Call 1-844-474-7464

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

Milk-of-Mag-lid-lab-01

2400 mg/30 mL

Case Label NDC 57237-314-31

Milk-of-Mag-case-lab-01

MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-314-31100 in 1 BOX, UNIT-DOSE07/05/2023
1NDC:57237-314-0330 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/05/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 7/2023
Document Id: 89c66f6b-a021-4605-9eb7-1bab14a27838
Set id: dfede6bd-df37-4f0f-9944-49dc13c967de
Version: 1
Effective Time: 20230705
 
Rising Pharma Holdings, Inc.