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.

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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

Otc - Do Not Use



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.

Otc - Pregnancy Or Breast Feeding



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


Otc - 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.


Package Label.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


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