Label: MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 64725-0649-1 - Packager: TYA Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 57896-649
- 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.
Drug Label Information
Updated May 2, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 15 mL tablespoonful)
- Purpose
- Uses
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Warnings
• kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days taking a prescription drug. This product may interact with certain prescription drugs. • 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 ask a health professional before use.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
If pregnant or breast-feeding,
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Directions
• 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 adults and children 12 years and older: 2 to 4 tablespoonfuls children 6 to 11 years: 1 to 2 tablespoonfuls children under 6 years: ask a doctor
- Other information
- Inactive ingredients
- MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID
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INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA ORIGINAL
magnesium hydroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64725-0649(NDC:57896-649) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) 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:64725-0649-1 16 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000 Labeler - TYA Pharmaceuticals (938389038) Registrant - TYA Pharmaceuticals (938389038) Establishment Name Address ID/FEI Business Operations TYA Pharmaceuticals 938389038 RELABEL(64725-0649) , REPACK(64725-0649)