Active Ingredients
Magnesium Aluminum Hydrate 100mg
Magnesium Oxide 50mg
Zantanol Tab.
FDA Label NDC 58354-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cho-a Pharm.co.,ltd. for the product Zantanol Tab. (NDC 58354-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, zantanol tab., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
* Please review the disclaimer below.
