Label: MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 0121-0527-10
- 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
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 10 mL)
- Purpose
- Uses
-
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 of 20 mL 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 mL (1 teaspoonful) children under 12 years of age ask a doctor As a Laxative
- do not exceed the maximum recommended daily dose 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
adults and children 12 years and older 15 mL to 30 mL children under 12 years ask a doctor -
Other information
- each teaspoonful (5 mL) contains: magnesium 1000 mg
- Sodium Content: 19 mg/10 mL
- store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
- Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:
NDC 0121-0527-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 10 mL Unit-Dose Cup Tray Label
NDC 0121-0527-10
Milk of Magnesia Concentrate
ANTACID/ SALINE LAXATIVE
Each 10 mL contains:
Magnesium Hydroxide
2400 mgSHAKE WELL
USUAL DOSAGE: See attached Drug Facts
This unit-dose package is not child-resistant.
Store at 20° - 25°C (68° - 77°F)
[See USP Controlled Room Temperature].Protect from freezing.
10 x 10 mL Unit-Dose Cups
Pharmaceutical
Associates, Inc.
Greenville, SC 29605T0527100318
R03/18 -
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0527 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 2400 mg in 10 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) CYCLOMETHICONE 4 (UNII: CZ227117JE) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0527-10 10 in 1 CASE 04/20/1982 1 10 in 1 TRAY 1 10 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 04/20/1982 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0527)