Label: MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 80447-649-12
- Packager: Fact Products
- 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.
Updated September 17, 2020
If you are a consumer or patient please visit this version.
- Active ingredient (in each 15 mL tablespoonful)
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
• 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
If pregnant or breast-feeding, ask a health professional before use.
• shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• 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
age dose adults and children 12 years and over 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?
- package label
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
magnesium hydroxide suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80447-649 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 WATER (UNII: 059QF0KO0R) SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80447-649-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2020 Labeler - Fact Products (052239835) Registrant - GCP Laboratories (965480861) Establishment Name Address ID/FEI Business Operations GCP Laboratories 965480861 manufacture(80447-649)