Label: MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 0121-0431-30
- Packager: PAI Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 5, 2022
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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 Drug M007 09/04/1979 Labeler - PAI Holdings, LLC (044940096) Establishment Name Address ID/FEI Business Operations PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 097630693 manufacture(0121-0431)
