NDC | 49631-212-01 |
Set ID | eea230ed-8d78-9355-81a7-d08722aed708 |
Category | HUMAN OTC DRUG LABEL |
Packager | OHTA'S ISAN CO., LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART331 |
- 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
-
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)