Ohtas Isan Antacid Powder
FDA Label NDC 49631-178

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ohta's Isan Co.,ltd. for the product Ohtas Isan Antacid (NDC 49631-178). 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 (in each spoonful), purpose, uses, warnings, ask a doctor or pharmacist before use if you are, if pregnant or breast-feeding,, direction, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Spoonful)

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ If Pregnant Or Breast-feeding,

→ Direction

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - Can Label

Active Ingredients (In Each Spoonful)

Precipitated calcium carbonate 497 mg
Sodium bicarbonate 600 mg

Purpose

Precipitated calcium carbonate ............. Antacid
Sodium bicarbonate ............................. Antacid

Uses

relieves: ■ heartburn ■ sour stomach ■ acid indigestion ■ upset stomach due to these symptoms

Warnings

Do not use more than 3 spoonfuls 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.