OHTAS ISAN ANTACID- calcium carbonate, sodium bicarbonate powder

OHTAS ISAN ANTACID by

Drug Labeling and Warnings

OHTAS ISAN ANTACID by is a Otc medication manufactured, distributed, or labeled by OHTA'S ISAN CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

Keep out of reach of children.

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.

Principal Display Panel - Can Label

Ohta's Isan NDC: 49631-178-21

ANTACID POWDER

NET WT 2.65 OZ (75g)

Principal Display Panel - Can Label

Ohta's Isan NDC: 49631-178-22

ANTACID POWDER

NET WT 4.94 OZ (140g)

INGREDIENTS AND APPEARANCE

OHTAS ISAN ANTACID 
calcium carbonate, sodium bicarbonate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49631-178
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Calcium Carbonate (UNII: H0G9379FGK) (Carbonate Ion - UNII:7UJQ5OPE7D)	Calcium Carbonate	1 g  in 1 g
Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20)	Sodium Bicarbonate	1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Cinnamon (UNII: 5S29HWU6QB)
Tangerine (UNII: KH3E3096OO)
Clove (UNII: K48IKT5321)
Fennel (UNII: 557II4LLC3)
Gentiana Lutea Root (UNII: S72O3284MS)
Levomenthol (UNII: BZ1R15MTK7)
Nutmeg (UNII: AEE24M3MQ9)
Picrasma Quassioides Wood (UNII: 75EIV4LX7W)
Magnesium Carbonate (UNII: 0E53J927NA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49631-178-21	1 in 1 BOX	10/16/2000
1		75 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 49631-178-22	1 in 1 BOX	10/16/2000
2		140 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	10/16/2000

Labeler - OHTA'S ISAN CO.,LTD. (690771738)

Establishment
Name	Address	ID/FEI	Business Operations
OHTA'S ISAN CO.,LTD.		715739137	MANUFACTURE(49631-178)