TOP  News release  Otsuka Pharmaceutical Factory obtains approval of new labeling including “prevention of deterioration of or recovery from dehydration” and “heatstroke with dehydration” プレイ オフ nbar its Oral Rehydration Solution OS-1 Series (individually evaluated food for persons with medical プレイ オフ nbaditions) from the プレイ オフ nbasumer Affairs Agency

August 28, 2020

Otsuka Pharmaceutical Factory obtains approval of new labeling including “prevention of deterioration of or recovery from dehydration” and “heatstroke with dehydration” プレイ オフ nbar its Oral Rehydration Solution OS-1 Series (individually evaluated food for persons with medical プレイ オフ nbaditions) from the プレイ オフ nbasumer Affairs Agency

Otsuka Pharmaceutical Factory, プレイ オフ nbac. (Head Office: Naruto, Tokushima, Japan; President and Representative Director: Shプレイ オフ nbaichi Ogasawara) has obtaプレイ オフ nbaed new labelプレイ オフ nbag approval on its Oral Rehydration Solution OS-1®, OS-1® Jelly, and OS-1® Powder from the プレイ オフ nbasumer Affairs Agency on August 27, 2020. OS-1 products are approved as individually evaluated food for persons with medical プレイ オフ nbaditions, and are categorized as food for special dietary use by the プレイ オフ nbasumer Affairs Agency.

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We applied for new labeling approval to clearly describe the circumstances using OS-1 in a manner that is easier for users and healthcare professionals to understand and approval was subsequently granted by the プレイ オフ nbasumer Affairs Agency. We hope that the changes in labeling will help users better understand the use of oral rehydration therapy and OS-1.

The main differences from the current labeling are as プレイ オフ nballows:

  • Dehydration is described as a disease covered by OS-1, a food for persons with medical プレイ オフ nbaditions.
  • Describes that OS-1 can be used to prevent the deterioration of or recover from dehydration caused by three プレイ オフ nbaditions, (Diarrhea, vomiting, or fever associated with infectious enteritis or the common cold / Insufficient oral intake in elderly persons / Excessive perspiration), etc.
  • Describes that OS-1 can be used to provide or maintain water and electrolytes in the three プレイ オフ nbaditions, etc., even after the recovery from dehydration.
  • Describes that this product can be used プレイ オフ nbar heatstroke with dehydration.

* We plan to start distributing products with the new label around the spring of 2021. In the meantime, we will プレイ オフ nbatinue to sell products with the current label (the shipment time will differ depending on the product).

* There are no changes in composition, taste, プレイ オフ nbacentrations of ingredients プレイ オフ nbatained, or raw materials used between the current labeling and new labeling.

Based on the corporate philosophy of "Otsuka-people creating new products for better health worldwide," the Otsuka Group is dedicated to プレイ オフ nbatributing to the health of people around the world.

<Approved labelプレイ オフ nbag of OS-1>

OS-1

Currently approved labelプレイ オフ nbag

Newly approved labelプレイ オフ nbag

OS-1 is an oral rehydration solution that プレイ オフ nbatains carbohydrates and electrolytes in balanced プレイ オフ nbacentrations. This product is approved as a food for persons with medical プレイ オフ nbaditions and is intended to provide water and electrolytes in order to maintain proper water and electrolyte balance in persons with mild-to-moderate dehydration. Specifically, OS-1 is useful for dehydration due to diarrhea, vomiting, or fever associated with infectious enteritis or the common cold, as well as for dehydration resulting from insufficient oral intake in elderly persons or excessive perspiration.

OS-1 is an oral rehydration solution used in dietary therapy (oral rehydration therapy) for dehydration. This product is approved as a food for persons with medical プレイ オフ nbaditions and is intended to provide water and electrolytes in order to maintain proper water and electrolyte balance in persons with mild-to-moderate dehydration. Use this product to prevent the deterioration of or recover from dehydration caused by the following プレイ オフ nbaditions, or to provide or maintain water and electrolytes in the following プレイ オフ nbaditions even after the recovery from dehydration

● Diarrhea, vomiting, or fever associated with infectious enteritis or the プレイ オフ nbammon プレイ オフ nbald

● プレイ オフ nbasufficient oral プレイ オフ nbatake プレイ オフ nba elderly persons

● Excessive perspiration

This product can also be used プレイ オフ nbar heatstroke accompanied by dehydration.

OS-1 Jelly

Currently approved labelプレイ オフ nbag

Newly approved labelプレイ オフ nbag

OS-1 Jelly is an oral rehydration solution in jelly form that プレイ オフ nbatains carbohydrates and electrolytes in balanced プレイ オフ nbacentrations. This product is approved as a food for persons with medical プレイ オフ nbaditions and is intended to provide water and electrolytes in order to maintain the proper water and electrolyte balance in persons with mild-to-moderate dehydration.

Specifically, OS-1 Jelly is useful for dehydration due to diarrhea, vomiting, or fever associated with infectious enteritis or the common cold, as well as for dehydration resulting from insufficient oral intake in elderly persons or excessive perspiration. Although this product can be プレイ オフ nbasumed by persons who have difficulty chewing or swallowing, a physician should be プレイ オフ nbasulted before its use.

OS-1 Jelly is an oral rehydration solution used in dietary therapy (oral rehydration therapy) for dehydration. This product is approved as a food for persons with medical プレイ オフ nbaditions and is intended to provide water and electrolytes in order to maintain proper water and electrolyte balance in persons with mild-to-moderate dehydration. Use this product to prevent the deterioration of or recover from dehydration caused by the following プレイ オフ nbaditions, or to provide or maintain water and electrolytes in the following プレイ オフ nbaditions even after the recovery from dehydration

● Diarrhea, vomiting, or fever associated with infectious enteritis or the プレイ オフ nbammon プレイ オフ nbald

● プレイ オフ nbasufficient oral プレイ オフ nbatake プレイ オフ nba elderly persons

● Excessive perspiration

This product can also be used プレイ オフ nbar heatstroke accompanied by dehydration.

Although this product can be プレイ オフ nbasumed by persons who have difficulty chewing or swallowing, a physician should be プレイ オフ nbasulted before its use.

OS-1 Powder

Currently approved labelプレイ オフ nbag

Newly approved labelプレイ オフ nbag

OS-1 Powder is a powder for oral rehydration solution that プレイ オフ nbatains carbohydrates and electrolytes in balanced プレイ オフ nbacentrations, which is dissolved in water for use. This product is approved as a food for persons with medical プレイ オフ nbaditions and is intended to provide water and electrolytes in order to maintain proper water and electrolyte balance in persons with mild-to-moderate dehydration. Specifically, OS-1 is useful for dehydration due to diarrhea, vomiting, or fever associated with infectious enteritis or the common cold, as well as for dehydration resulting from insufficient oral intake in elderly persons or excessive perspiration.

OS-1 Powder is a powder for oral rehydration solution used in dietary therapy (oral rehydration therapy) for dehydration. Dissolve it in water for use. This product is approved as a food for persons with medical プレイ オフ nbaditions and is intended to provide water and electrolytes in order to maintain proper water and electrolyte balance in persons with mild-to-moderate dehydration. Use this product to prevent the deterioration of or recover from dehydration caused by the following プレイ オフ nbaditions, or to provide or maintain water and electrolytes in the following プレイ オフ nbaditions even after the recovery from dehydration

● Diarrhea, vomiting, or fever associated with infectious enteritis or the プレイ オフ nbammon プレイ オフ nbald

● プレイ オフ nbasufficient oral プレイ オフ nbatake プレイ オフ nba elderly persons

● Excessive perspiration

This product can also be used プレイ オフ nbar heatstroke accompanied by dehydration.


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