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Milk of Magnesia by Rij Pharmaceutical Corporation

Medically reviewed on April 3, 2018

Dosage form: liquid
Ingredients: MAGNESIUM HYDROXIDE 400mg in 5mL
Labeler: Rij Pharmaceutical Corporation
NDC Code: 53807-401

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.

Drug Facts

Active Ingredient (in each 5 mL) One teaspoonful)

Magnesium Hydroxide 400 mg

Purpose

Saline laxative/Antacid

Use

Laxative

relieves occasional constipation (irregularity).
generally produces bowel movement in ½ to 6 hours.

Antacid

relieves acid indigestion, sour stomach, heartburn.

Warnings

Ask a doctor before use if you have
kidney disease
stomach pain, nausea or vomiting
notice a sudden change in bowel habits that persists over a period of 2 weeks
a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacid may interact with certain prescription drugs.

When using this product
it may have a laxative effect
do not exceed the maximum recommended daily dosgae in a 24-hour period

Stop use and ask a doctor if

Laxative

you have rectal bleeding or failure to have a bowel movement after use. These may indicate a serious condition.
you need to use a laxative for more than one week

Antacid

symptoms last for more than 2 weeks.

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 immediately.

Directions
shake well before use
Laxative use:Antacid use

Do not use dosage cup for ages under 12 years.

Follow each dose with a full glass (8 oz) of liquid.

Do not use dosage cup.

Follow each dose with a little water.

adults and children 12 years and older2-4 TBSP (30-60 mL) once a day1-3 tsp (5-15 mL) up to 4 times a day
6 to 11 years1-2 TBSP (15-30 mL) once a dayask a doctor
2 to 5 years1-3 tsp (5-15 mL) once a dayask a doctor
under 2 yearsask a doctorask 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 teaspoon (5 mL) contains: magnesium 166 mg
each teaspoon (5 mL) contains: sodium 1 mg

Inactive ingredients

citric acid, flavor, purified water, sodium hypochlorite.

Principal Display Panel
MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
WATER 
SODIUM HYPOCHLORITE 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53807-401-12355 mL in 1 BOTTLE
2NDC:53807-401-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)

 
Rij Pharmaceutical Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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