FDA Label for Ohtas Isan Antacid
View Indications, Usage & Precautions
Ohtas Isan Antacid Product Label
The following document was submitted to the FDA by the labeler of this product Ohta's Isan Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Tablet)
Magnesium aluminometasilicate 83.3 mg
Precipitated calcium carbonate 133.3 mg
Sodium bicarbonate 133.3 mg
Purpose
Magnesium aluminometasilicate ............ Antacid
Precipitated calcium carbonate ............. Antacid
Sodium bicarbonate ............................. Antacid
Uses
relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms
Warnings
Do not use more than 9 tablets 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 doctor.
Ask A Doctor Or Pharmacist Before Use If You Are
■ presently taking a prescription drug. Antacids may interact with certain prescription drugs
■ on a sodium-restricted diet
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Direction
swallow 3 tablets with a glass of water after meals, 3 times daily
Other Information
■ each tablet contains: sodium 36.7 mg. ■ keep the carton. It contains important information.
■ store at 20°-25°C (68°-77°F) ■ protect from moisture
Inactive Ingredients
cinnamon bark, cinnamon oil, citrus unshiu peel, clove, fennel, fennel oil, gentian, lemon oil, menthol, magnesium stearate, microcrystalline cellulose, nutmeg, powdered picrasma wood.
Principal Display Panel
NDC 49631-212-01
Ohta's Isan ANTACID TABLETS
Heartburn Acid Indigestion Upset Stomach
45 TABLETS
Manufactured by
OHTA'S ISAN CO., LTD.
3-2, SENGOKU 2-CHOME, BUNKYO-KU,
TOKYO 112-0011, JAPAN
PRODUCT OF JAPAN
DO NOT USE IF A CARTON IS DAMAGED OR FOIL SEAL IS BROKEN.
Lot. No.
Exp. Date
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