Label: MILK OF MAGNESIA- magnesium hydroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-401-12, 53807-401-16 - Packager: Rij Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated April 30, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient (in each 5 mL) One teaspoonful)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
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- kidney disease
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- stomach pain, nausea or vomiting
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- notice a sudden change in bowel habits that persists over a period of 2 weeks
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- 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
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- it may have a laxative effect
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- do not exceed the maximum recommended daily dosgae in a 24-hour period
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Directions
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- 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 older 2-4 TBSP (30-60 mL) once a day 1-3 tsp (5-15 mL) up to 4 times a day 6 to 11 years 1-2 TBSP (15-30 mL) once a day ask a doctor 2 to 5 years 1-3 tsp (5-15 mL) once a day ask a doctor under 2 years ask a doctor ask a doctor - Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-401 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) Product Characteristics Color WHITE (opaque) Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-401-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 2 NDC:53807-401-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-401)