Label: MAGNESIUM HYDROXIDE- magnesium hydroxide liquid
- NDC Code(s): 21695-903-16
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0536-2470
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 21, 2011
If you are a consumer or patient please visit this version.
- Active ingredient
Magnesium Hydroxide 400mgClose
Saline Laxative / AntacidClose
- Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away.Close
Laxative: relieves occasional constipation; generally produces a bowel movement in 1/2 to 6 hours.
Antacid: relieves heartburn, sour stomach & acid indigestion.Close
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.Close
- Other Information
each 5 mL teaspoon contains: magnesium 165mg and sodium 2 mg
store at room temperature
protect from freezing
keep tightly closedClose
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
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
adults and children 12 years and older: 1 to 3 teaspoons with water, up to 4 times daily
children under 12 years: ask a doctorClose
- Inactive ingredients
flavor, purified water, saccharin sodium, sodium hypochlorite
Questions or comments? Call 1-800-645-2158, 9 am - 5 pm EST, Monday-FridayClose
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
magnesium hydroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-903(NDC:0536-2470) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE 400 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-903-16 473 mL in 1 BOTTLE 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 Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK