SPL v6
SPL
SPL Set ID 53380470-5748-6fa7-548e-7484ef204c0f
Route
ORAL
Published
Effective Date 2019-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (1 g) Bicarbonate Ion
Inactive Ingredients
Cinnamon Tangerine Clove Fennel Gentiana Lutea Root Levomenthol Nutmeg Picrasma Quassioides Wood Magnesium Carbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-10-16

Description

Precipitated calcium carbonate         497 mg  Sodium bicarbonate                         600 mg

Purpose

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


Medication Information

Purpose

Precipitated calcium carbonate ............. Antacid

Sodium bicarbonate ............................. Antacid

Description

Precipitated calcium carbonate         497 mg  Sodium bicarbonate                         600 mg

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.

Direction

take 1 spoonful (using the spoon included with this can) with water, 3 times daily.

Other Information

each spoonful contains: sodium 164 mg.

Inactive Ingredients

cinnamon bark, citrus unshiu peel, clove, fennel, gentian,  l-menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Principal Display Panel Can Label

Ohta's Isan NDC 49631-178-21

ANTACID POWDER

NET WT 2.65 OZ (75g)

Active Ingredients (in Each Spoonful)

Precipitated calcium carbonate         497 mg 

Sodium bicarbonate                         600 mg

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.


Structured Label Content

Uses

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

Purpose

Precipitated calcium carbonate ............. Antacid

Sodium bicarbonate ............................. Antacid

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.

Direction

take 1 spoonful (using the spoon included with this can) with water, 3 times daily.

Other Information

each spoonful contains: sodium 164 mg.

Inactive Ingredients (Inactive ingredients)

cinnamon bark, citrus unshiu peel, clove, fennel, gentian,  l-menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Principal Display Panel Can Label (Principal Display Panel - Can Label)

Ohta's Isan NDC 49631-178-21

ANTACID POWDER

NET WT 2.65 OZ (75g)

Active Ingredients (in Each Spoonful) (Active Ingredients (in each spoonful))

Precipitated calcium carbonate         497 mg 

Sodium bicarbonate                         600 mg

Ask A Doctor Or Pharmacist Before Use If You Are (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.


Advanced Ingredient Data


Raw Label Data

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