Label: OHTAS ISAN ANTACID- magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49631-212-01 - Packager: OHTA'S ISAN CO., LTD
- 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 June 7, 2012
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- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor or pharmacist before use if you are
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Direction
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHTAS ISAN ANTACID
magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49631-212 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Almasilate (UNII: OZQ8O62H53) (Almasilate - UNII:OZQ8O62H53) Almasilate 83.3 mg Calcium Carbonate (UNII: H0G9379FGK) (Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate 133.3 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate 133.3 mg Inactive Ingredients Ingredient Name Strength Cinnamon (UNII: 5S29HWU6QB) Cinnamon Oil (UNII: E5GY4I6YCZ) Tangerine (UNII: KH3E3096OO) Clove (UNII: K48IKT5321) Clove Oil (UNII: 578389D6D0) Fennel (UNII: 557II4LLC3) Fennel Oil (UNII: 59AAO5F6HT) Gentiana Lutea Root (UNII: S72O3284MS) Lemon Oil (UNII: I9GRO824LL) Menthol (UNII: L7T10EIP3A) Magnesium Stearate (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) Nutmeg (UNII: AEE24M3MQ9) Picrasma Quassioides Wood (UNII: 75EIV4LX7W) Product Characteristics Color YELLOW (Pale Yellow) Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49631-212-01 1 in 1 CARTON 1 45 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/01/2012 Labeler - OHTA'S ISAN CO., LTD (690771738)