NDC | 58354-101-01, 58354-101-02 |
Set ID | 9b3092fa-86e6-469d-8f73-0626e4c12a28 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cho-A Pharm.Co.,Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART331 |
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
-
Warnings
For oral use only
Use only the recommended dosage
Do not use if you have
• hemodyscrasia
• kidney, liver, bowel, stomach, and duodenum disease
• immunological disorder (asthma,rheumatism)
• previously experienced sensitivity to this medication
• dialysisDo not use if the user under 15 and over 80 years old.
When using this product
• do not take other stomach medicine.
• do not take alcoholAsk a doctor, dentist, or pharmacist before use if the user
• take other medication
• take medical treatment
• have allergic reaction for drug
• are over 65 years old
• have sore throat, cough, or fever
• are having continuously stomachaches
• have kidney diseaseIf pregnant or breast-feeding, ask a health professional before use.
Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage.
- Directions
- Inactive Ingredients
- Zantanol Tab.
-
INGREDIENTS AND APPEARANCE
ZANTANOL TAB.
magnesium oxide, magnesium aluminum hydrate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58354-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 50 mg in 424 mg MAGALDRATE (UNII: 6V88E24N5T) (MAGALDRATE ANHYDROUS - UNII:0MFM55849I) MAGALDRATE 50 mg in 424 mg Inactive Ingredients Ingredient Name Strength ALMASILATE (UNII: OZQ8O62H53) RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (8% HYDROXYPROPYL: 140000 MW) (UNII: U466TXA0AK) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) water (UNII: 059QF0KO0R) Product Characteristics Color white Score no score Shape capsule Size 13mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58354-101-02 10 in 1 PACKAGE 02/28/2017 1 NDC:58354-101-01 424 mg in 1 CAPSULE; 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 02/28/2017 Labeler - Cho-A Pharm.Co.,Ltd. (688056831) Registrant - Cho-A Pharm.Co.,Ltd. (688056831) Establishment Name Address ID/FEI Business Operations Cho-A Pharm.Co.,Ltd. 688056831 manufacture(58354-101)