ZANTANOL TAB.- magnesium oxide, magnesium aluminum hydrate tablet 
Cho-A Pharm.Co.,Ltd.

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.

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Zantanol Tab.

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

ZANTANOL TAB. 
magnesium oxide, magnesium aluminum hydrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE50 mg
MAGALDRATE (UNII: 6V88E24N5T) (MAGALDRATE ANHYDROUS - UNII:0MFM55849I) MAGALDRATE100 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:58354-120-0220 in 1 PACKAGE01/31/2020
1NDC:58354-120-01424 in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/31/202005/18/2023
Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
Establishment
NameAddressID/FEIBusiness Operations
Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-120)

Revised: 5/2023
 
Cho-A Pharm.Co.,Ltd.