Label: OHTAS ISAN ANTACID- magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49631-182-11 - Packager: OHTA'S ISAN CO., LTD
- 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 June 7, 2012
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- 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
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PRINCIPAL DISPLAY PANEL
NDC 49631-182-11
Ohta's Isan
ANTACID TABLETS
Herb Flavored Antacid for the relief of heartburn, sour stomach, acid indigestion and upset stomach associated with these symptoms.
40 CHEWABLE TABLETS IN FOIL PACKET
Manufactured by
OHTA'S ISAN CO., LTD.
3-2, SENGOKU 2-CHOME, BUNKYO-KU,
TOKYO 112-0011, JAPAN
DO NOT USE IF A CARTON IS DAMAGED OR FOIL PACK EACH TABLET SEALED IN IS BROKEN
PRODUCT OF JAPAN
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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:49631-182 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Almasilate (UNII: OZQ8O62H53) (Almasilate - UNII:OZQ8O62H53) Almasilate 125 mg Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate 200 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate 200 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 BROWN (Sand Color) Score no score Shape ROUND Size 12mm Flavor Imprint Code OHTA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49631-182-11 1 in 1 CARTON 1 40 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/16/2000 Labeler - OHTA'S ISAN CO., LTD (690771738)