OTC Medication Information: Magnesium Hydroxide

MAGNESIUM HYDROXIDE- magnesium hydroxide liquid
Rebel Distributors Corp

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.

Active ingredient

Magnesium Hydroxide 400mg

Purpose

Saline Laxative / Antacid

Keep Out of Reach of Children

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

Uses

Laxative: relieves occasional constipation; generally produces a bowel movement in 1/2 to 6 hours.

Antacid: relieves heartburn, sour stomach & acid indigestion.

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 over 2 weeks

Ask a doctor or pharmacist before use if you are taking any other drug.

° antacids may interact with certain prescription drugs ° laxatives may affect how other drugs work, so should be taken 2 or more hours before or after other drugs.

When using this product as an antacid, it may have a laxative effect.

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 1 week ° symptoms last more than 2 weeks.

If pregnant or breast-feeding , ask a health professional before use.

Other Information

each 5 mL teaspoon contains: magnesium 165mg and sodium 2 mg

store at room temperature

protect from freezing

keep tightly closed

Directions

Laxative : ° shake well before using

° drink a full glass (8 ounces) of liquid with each dose

° may be taken as a single or divided dose

Antacid: ° do not take more than 12 teaspoons in 24 hours

° do not use maximum dosage for more than 2 weeks

Laxative:

adults and children 12 years and older: 2 to 4 tablespoons

children 6 to under 12 years: 1 to 2 tablespoons

children 2 to under 6 years: 1 to 3 teaspoons

children under 2 years: ask a doctor

Antacid:

adults and children 12 years and older: 1 to 3 teaspoons with water, up to 4 times daily

children under 12 years: ask a doctor

Inactive ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

Questions or comments? Call 1-800-645-2158, 9 am — 5 pm EST, Monday-Friday

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Milk of Magnesia
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MAGNESIUM HYDROXIDE
magnesium hydroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-903(NDC:0536-2470)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SACCHARIN SODIUM
SODIUM HYPOCHLORITE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-903-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 03/22/2010
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2011 Rebel Distributors Corp

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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