ZANTANOL TAB. (MAGNESIUM OXIDE, MAGNESIUM ALUMINUM HYDRATE) TABLET [CHO-A PHARM.CO.,LTD.]

ZANTANOL TAB. (MAGNESIUM OXIDE, MAGNESIUM ALUMINUM HYDRATE) TABLET [CHO-A PHARM.CO.,LTD.]
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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

    Magnesium Aluminum Hydrate 100mg

    Magnesium Oxide 50mg

  • Purpose

    Antacid

  • Keep out of reach of children

    • In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

    Helps relieve symptoms associated with indigestion: pain in the upper abdomen, heartburn, indigestion, nausea.

  • 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
    • dialysis

    Do 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 alcohol

    Ask 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 disease

    If 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

    • do not take more than the recommended dose
    • adults (over 15 and under 80 years old): take 2 tablets per session. After 5 hours if symptoms last 0.5-1g per session, 1-3 times per day, before meal. Do not take over 4 tablets a day.

  • Inactive Ingredients

    Ranitidine Hydrochloride, Magnesium Aluminosilicate, Low Substituted Hydroxypropylcellulose, Crospovidone, Hydroxypropylcellulose, Magnesium Stearate, Opadry white 80W68912, Purified Water

  • Zantanol Tab.

    zantanol

  • INGREDIENTS AND APPEARANCE
    ZANTANOL TAB. 
    magnesium oxide, magnesium aluminum hydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE50 mg  in 424 mg
    MAGALDRATE (UNII: 6V88E24N5T) (MAGALDRATE ANHYDROUS - UNII:0MFM55849I) MAGALDRATE50 mg  in 424 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapecapsuleSize13mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58354-101-0210 in 1 PACKAGE02/28/2017
    1NDC:58354-101-01424 mg in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/28/2017
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-101)

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