Label: OHTAS ISAN ANTACID- calcium carbonate, sodium bicarbonate powder
- NDC Code(s): 49631-178-21, 49631-178-22
- 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 November 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each spoonful)
- 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 - Can Label
- Principal Display Panel - Can Label
-
INGREDIENTS AND APPEARANCE
OHTAS ISAN ANTACID
calcium carbonate, sodium bicarbonate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49631-178 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 1 g in 1 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1 g in 1 g Inactive Ingredients Ingredient Name Strength CINNAMON (UNII: 5S29HWU6QB) TANGERINE (UNII: KH3E3096OO) CLOVE (UNII: K48IKT5321) FENNEL (UNII: 557II4LLC3) GENTIANA LUTEA ROOT (UNII: S72O3284MS) LEVOMENTHOL (UNII: BZ1R15MTK7) NUTMEG (UNII: AEE24M3MQ9) PICRASMA QUASSIOIDES WOOD (UNII: 75EIV4LX7W) MAGNESIUM CARBONATE (UNII: 0E53J927NA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49631-178-21 1 in 1 BOX 10/16/2000 1 75 g in 1 CAN; Type 0: Not a Combination Product 2 NDC:49631-178-22 1 in 1 BOX 10/16/2000 2 140 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 10/16/2000 Labeler - OHTA'S ISAN CO.,LTD. (690771738) Establishment Name Address ID/FEI Business Operations OHTA'S ISAN CO.,LTD. 715739137 manufacture(49631-178)