Label: MAGNESIUM OXIDE tablet
- NDC Code(s): 71610-172-60
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 54738-973
- 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 October 25, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (In each tablet)
- USES
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WARNINGS
Ask a doctor or pharmacist before use if you are:
taking a prescription drug. Antacids may interact with certain prescription drugs.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- Questions or Comments
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Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 400 mg 90 71610-172-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20181025JH - PRINCIPAL DISPLAY PANEL - 400 mg
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INGREDIENTS AND APPEARANCE
MAGNESIUM OXIDE
magnesium oxide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-172(NDC:54738-973) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 400 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (Off) Score no score Shape ROUND Size 12mm Flavor Imprint Code AP;136 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-172-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/01/2016 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-172)
