Otc - Active Ingredient
Active ingredients (in each bottle)
Magnesium Aluminosilicate 900 mg
Magnesium Hydroxide 250 mg
Inon Ace Solution
FDA Label NDC 49873-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Inon Ace (NDC 49873-403). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Magnesium Aluminosilicate Antacid
Magnesium Hydroxide Antacid
Indications & Usage
Uses relieves these symptoms:
■ heartburn ■ sour stomach ■ acid indigestion
Warnings
Warnings
Otc - Do Not Use
Do not use this product if you are taking a prescription antibiotic drug containing any
form of tetracycline.
Otc - Ask Doctor
Ask a doctor or pharmacist before use if you are presently taking a prescription drug.
Antacids may interact with certain prescription drugs.
Otc - When Using
When using this product
■ do not take more than 2 bottles (adults and children 12 years and over) in a 24-hour
period or use the maximum dosage of this product for more than 2 weeks, except under
the advice and supervision of a physician.
■ may have a laxative effect.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
■ adults and children 12 years and over: Take 1 bottle (30mL) at a time 2 times daily,
between meals, or as directed by a doctor.
■ children under 12 years: Ask a doctor.
■ shake well before use.
Other Safety Information
Other information
■ each bottle contains: sodium 15 mg, magnesium 165 mg
Inactive Ingredient
Inactive ingredients alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluid
extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor
oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.
* Please review the disclaimer below.
