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Milk of Magnesia by REMEDYREPACK INC.

Medically reviewed on April 11, 2017

Dosage form: concentrate
Ingredients: MAGNESIUM HYDROXIDE 2400mg in 10mL
Labeler: REMEDYREPACK INC.
NDC Code: 61786-406

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

CONCENTRATED Milk of Magnesia (Lemon Flavored)

Drug Facts

Serving Size: 10 mL (2 teaspoonful)

Active Ingredient (per 10 mL)

Purpose

Magnesium hydroxide 2400 mg

Laxative

Active Ingredient per 10 mL

Magnesium hydroxide 2400 mg

Purpose

Laxative

Keep Out of Reach of Children

Warnings

Ask a doctor before us if you have:

  • Kidney disease
  • Stomach pain, nausea or vomiting
  • A magnesium restricted diet
  • A sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

This package bears a tamper evident seal. If the seal is broken, do not use.

Suggested Uses
  • Relieves occasional constipation (irregularity).

This product usually produces bowel movement in 1/2 to 6 hours.

Directions
  • Shake well before use – Do not dilute.
  • 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

10 to 20 mL (2 to 4 tsp.)

Children 6 to 11 Years

5 to 10 mL (1 to 2 tsp.)

Children under 6 Years

Ask a Doctor

Other Information
  • 10 mL contains: magnesium 1000 mg
  • 10 mL contains: sodium 21 mg

Storage and Handling

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

Do not freeze, keep tightly closed.

Inactive Ingredients

Benzyl alcohol, carboxymethylcellulose sodium, citric acid anhydrous, glycerin, lemon oil, purified water, sodium citrate, sodium hexametaphosphate, sodium hyprochlorite, sorbitol, sucrose, vanillin.

Questions or Comments?

Call toll free 1-800-962-8364. You may also report serious side effects to this phone number

Distr. by: West-Ward
Pharmaceutical Corp.

Eatontown, NJ 07724

Revised August 2016

DRUG: Milk of Magnesia

GENERIC: Milk of Magnesia

DOSAGE: CONCENTRATE

ADMINSTRATION: ORAL

NDC: 61786-406-30

PACKAGING: 400 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • MAGNESIUM HYDROXIDE 2400mg in 10mL

INACTIVE INGREDIENT(S):

  • BENZYL ALCOHOL
  • SUCROSE
  • SORBITOL
  • SODIUM CITRATE, UNSPECIFIED FORM
  • VANILLIN
  • CARBOXYMETHYLCELLULOSE
  • ANHYDROUS CITRIC ACID
  • GLYCERIN
  • SODIUM POLYMETAPHOSPHATE
  • LEMON OIL
  • WATER

MILK OF MAGNESIA 
milk of magnesia concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-406(NDC:0054-3567)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE2400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
ANHYDROUS CITRIC ACID 
GLYCERIN 
LEMON OIL 
WATER 
SODIUM POLYMETAPHOSPHATE 
SORBITOL 
SUCROSE 
VANILLIN 
SODIUM CITRATE, UNSPECIFIED FORM 
CARBOXYMETHYLCELLULOSE 
Packaging
#Item CodePackage Description
1NDC:61786-406-30400 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/04/2015
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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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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