Label: MILK OF MAGNESIA- magnesium hydroxide suspension
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- NDC Code(s): 0121-0431-30
- Packager: Pharmaceutical Associates, Inc.
- 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.
Drug Label Information
Updated January 5, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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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 14 days
Ask a doctor or pharmacist before use If you are taking a prescription drug. This product may interact with certain prescription drugs.
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Directions
As an Antacid
- do not exceed the maximum recommended daily dose in a 24 hour period
- shake well before use
- can be taken with water
- mL = milliliter
adults and children 12 years of age and over 5 to 15 mL (1 to 3 teaspoonfuls) children under 12 years of age ask a doctor As a Laxative
- do not exceed the maximum recommended daily dose of 60 mL in a 24 hour period
- shake well before use
- 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.
- mL = milliliter; TBSP = Tablespoon
adults and children 12 years and older 30 mL (2 TBSP) to 60 mL (4 TBSP) children 6 – 11 years 15 mL (1 TBSP) to 30 mL (2 TBSP) children under 6 years ask a doctor -
Other information
- each teaspoonful (5 mL) contains: magnesium 400 mg
- store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
- Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:
NDC 0121-0431-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each. - Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label
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INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0431 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 HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0431-30 10 in 1 CASE 09/04/1979 1 10 in 1 TRAY 1 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 09/04/1979 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0431)
