ZANTANOL TAB.- magnesium oxide, magnesium aluminum hydrate tablet

Zantanol Tab. by

Drug Labeling and Warnings

Zantanol Tab. by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

ZANTANOL TAB. 
magnesium oxide, magnesium aluminum hydrate tablet

Product 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)