Otc - Active Ingredient
Active ingredients (in each tablet)
Magnesium Aluminosilicates 200 mg
Magnesium Hydroxide 60 mg
Simethicone 20 mg
Inon Ace Tablet
FDA Label NDC 49873-402
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 49873-402). 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 - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, 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
Purposes
Magnesium Aluminosilicates Antacid
Magnesium Hydroxide Antacid
Simethicone Antigas
Indications & Usage
Uses relieves these symptoms
■heartburn ■acid indigestion ■sour stomach
■upset stomach and gas associated with these symptoms
Warnings
Enter section text here
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
■taking a prescription drug. Antacids may interact with certain prescription drugs
Otc - When Using
When using this product
■Do not take more than 9 tablets in 24-hours period or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
■Adults and children 12 years of age and over: Take 3 tablets with water 3 times daily between meals and at bedtime, or as directed by a doctor.
■Children under 12 years: Ask a doctor.
Other Safety Information
Other information
■Each tablet contains: sodium 8 mg, magnesium 35 mg
■Do not purchase if printed seal with “sato” is broken or missing from top or bottom of carton.
Inactive Ingredient
Inactive ingredients caramel, colloidal silicon dioxide, croscarmellose sodium, flavor, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, synthetic iron oxide
Package Label.Principal Display Panel
Carton (Inontabcart)
* Please review the disclaimer below.
