Label: STOMACHIN ANTACID- magnesium carbonate and sodium bicarbonate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 43337-9329-7, 43337-9329-8, 43337-9329-9 - Packager: Chang Kuo Chou Pharmaceutical 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 December 14, 2022
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- ACTIVE INGREDIENT
- Uses
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Warnings
Do not use more than 3 packets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 g Packet Box
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INGREDIENTS AND APPEARANCE
STOMACHIN ANTACID
magnesium carbonate and sodium bicarbonate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43337-9329 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 58 mg in 1 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 809 mg in 1 g Inactive Ingredients Ingredient Name Strength CLOVE (UNII: K48IKT5321) 29 mg in 1 g LICORICE (UNII: 61ZBX54883) 86 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) 4 mg in 1 g RHUBARB (UNII: G280W4MW6E) 14 mg in 1 g Product Characteristics Color WHITE (beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43337-9329-8 450 g in 1 CAN; Type 0: Not a Combination Product 04/30/2009 2 NDC:43337-9329-7 95 g in 1 CAN; Type 0: Not a Combination Product 04/30/2009 3 NDC:43337-9329-9 20 in 1 BOX 04/30/2009 3 2 g in 1 PACKET; 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 04/30/2009 Labeler - Chang Kuo Chou Pharmaceutical Co., Ltd. (656241486) Establishment Name Address ID/FEI Business Operations Chang Kuo Chou Pharmaceutical Co., Ltd. 656241486 MANUFACTURE(43337-9329)