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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each packet <1.3g>)

Precipitated calcium carbonate 497 mg

Sodium bicarbonate 600 mg

Purpose

Antacid

Antacid

Uses

relieves:

• heartburn
• sour stomach
• acid indigestion
• upset stomach due to these symptoms

Warnings

Do not take more than 3 packets 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 of a pharmacist before use if you are

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.
• on a sodium-restricted diet.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Direction

take 1 packet with water, 3 times daily, or as directed by a physician.

Other information

each packet contains: sodium 164 mg.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 16 Packets Box Label

NDC: 49631-178-13

Graphic – Ohta's Isan Logo

Ohta's Isan ANTACID POWDER

Heartburn Herb Flavored

Acid Upset

Indigestion Stomach

OHTA'S ISAN MADE IN JAPAN 16 Packets

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: 49631-178-13	1 in 1 BOX	07/01/2017
1		16 in 1 DOSE PACK
1		1.3 g in 1 PACKET; 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	07/01/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
OHTA'S ISAN CO.,LTD.		715739137	ANALYSIS(49631-178) , MANUFACTURE(49631-178) , PACK(49631-178) , PARTICLE SIZE REDUCTION(49631-178) , STERILIZE(49631-178)