MAGNESIUM OXIDE, Magnesium Aluminum Hydrate

Manufacturer
Cho-A Pharm.Co.,Ltd.
Effective date
2023-03-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:34:11

Label at a glance#

ProductZantanol Tab.
Active ingredientMAGNESIUM OXIDE, MAGALDRATE
Label structure8 sections

Indications and uses

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

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Magnesium Aluminum Hydrate 100mg

Magnesium Oxide 50mg

Purpose

OTC - PURPOSE SECTION

Antacid

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Zantanol Tab.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zantanolzantanol

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58354-120-022023-03-20C16284748780-1f386c649-b9b8-0266-e053-dadaa90a7c1aZantanol Tab.
58354-120-022023-01-30C16284748780-1f386c649-b9b8-0266-e053-dadaa90a7c1aZantanol Tab.

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58354-12058354-120-01, 58354-120-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1b8cb387-7540-ba44-e063-6294a90ac87f9d797a17-1661-f767-e053-2995a90a143d2024-06-23WarningsExact identifier
spl set id: 9d797a17-1661-f767-e053-2995a90a143d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.