Otc - Active Ingredient
Active ingredients [in each packet (1.92g)]
Aluminum hydroxide 400 mg
Magnesium carbonate 400 mg
Sodium bicarbonate 700 mg
Inon Granule
FDA Label NDC 49873-045
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 (NDC 49873-045). 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, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Aluminum hydroxide Antacid
Magnesium carbonate Antacid
Sodium bicarbonate Antacid
Indications & Usage
Uses relieves these symptoms
■ heartburn ■ sour stomach ■ acid indigestion
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if you have
■ a sodium-restricted diet
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 3 packets 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 doctor
■ May have laxative effect
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ Adults and children 12 years of age and over: Take 1 packet at a time 3 times daily between meals or after meals, or as directed by a doctor
■ Children under 12 years: Ask a doctor
Other Safety Information
Other information ■ Each packet contains: sodium 175 mg, magnesium 95 mg
Inactive Ingredient
Inactive ingredients colloidal silicon dioxide, flavor, partially hydrolyzed polyvinyl alcohol, sugar, starch
Package Label.Principal Display Panel
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