Label: LEADER MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 70000-0483-1
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
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.
Updated June 21, 2021
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- Active ingredient (in each 15 mL)
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 more than 2 weeks
Ask a doctor or pharmacist before use if you are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
- 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, use dose cup provided
- mL = milliliter
adults and children 12
years and older
30 mL to 60 mL
children 6 to 11 years
15 mL to 30 mL
children under 6 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
LEADER MILK OF MAGNESIA
magnesium hydroxide suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0483 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 LIGHT MINERAL OIL (UNII: N6K5787QVP) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PEPPERMINT OIL (UNII: AV092KU4JH) Product Characteristics Color WHITE (opaque) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0483-1 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/20/2019 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)