Label: MILK OF MAGNESIA- magnesium hydroxide liquid
- Label RSS
- Share
- NDC Code(s): 58602-321-16, 58602-321-32
- Packager: Aurohealth LLC
- 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 November 16, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Use
-
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.
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- 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.
- for accurate dosing, only use the dosing cup provided
- do not use any other dosing device
- TBSP = Tablespoon, mL = milliliter
age
dose
adults and children 12 years and older
30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years
15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 years
ask a doctor
Other information
- each tablespoon (15 mL) contains : calcium 20 mg, magnesium 500 mg, and sodium 1.43 mg
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F) and avoid freezing. Close cap tightly after use.
-
Inactive ingredients
D&C Red No. 28, flavor, glycerin, purified water, saccharin sodium, xanthan gum.
Questions or comments?
1-855-274-4122
* This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Phillips’® Milk of Magnesia.
Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648 -
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle
AUROHEALTH
NDC 58602-321-16
*Compare to the active ingredient
in Phillips’® Milk of Magnesia
Milk of
Magnesia
Saline Laxative
Each 15 mL (1TBSP) dose of
oral solution contains:
1200 mg - Magnesium hydroxide USP- Very low sodium
- Sugar Free
- Stimulant Free
- Comfortable, Cramp Free Relief
Contains: Less than 0.5% alcohol
TAMPER-EVIDENT: Do not use
if imprinted neckband is missing or broken.
Cherry Flavor 12 FL OZ (355 mL)
-
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-321 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 1200 mg in 15 mL Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH) CHERRY (UNII: BUC5I9595W) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK (Pink to Light Pink) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-321-16 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/28/2016 09/01/2022 2 NDC:58602-321-32 769 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/28/2016 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/28/2016 09/01/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-321)