MILK OF MAGNESIA- magnesium hydroxide liquid 
RIJ Pharmaceutical Corporation

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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Drug Facts

Active Ingredient (in each 15 mL Tablespoon)

Magnesium Hydroxide 1200 mg

Purpose

Saline laxative

Use

relieves occasional constipation (irregularity).
This product generally 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 more than 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 one 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.

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
mL = milliliter, TBSP = Tablespoonful

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

TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
Store at room temperature 15º - 30ºC (59º - 86ºF)
keep tightly closed
keep from freezing
each tablespoon (15 mL) contains: magnesium 498 mg
each tablespoon (15 mL) contains: sodium 3 mg

Inactive ingredients

citric acid, purified water, sodium hypochlorite

Principal Display Panel

Milk of Magnesia Label

MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-125
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-125-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
2NDC:53807-125-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
3NDC:53807-125-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/16/1999
Labeler - RIJ Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
RIJ Pharmaceutical Corporation144679156manufacture(53807-125)

Revised: 4/2018
Document Id: 5efac10b-340b-46f4-8cea-219d9034ca5b
Set id: a0d52a58-e7a6-41ac-8f32-55cba99c5cf4
Version: 2
Effective Time: 20180430
 
RIJ Pharmaceutical Corporation