53380470-5748-6fa7-548e-7484ef204c0f

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

Purpose

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

Description

Precipitated calcium carbonate         497 mg  Sodium bicarbonate                         600 mg


Medication Information

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.

Uses

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

Purpose

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

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

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.

Description

Precipitated calcium carbonate         497 mg  Sodium bicarbonate                         600 mg

Direction

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

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

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.

Uses

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

Purpose

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

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

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.

Direction

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

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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