Kracie Kampo Otsujito Extract Tablets 180 Tablets [Class 2 OTC Drug]

Product Information

●"Otsujito" is a formula that was created by Hara Nanyo, a renowned physician of the Edo period, as a Kampo prescription specifically for "ji-shitsu" (hemorrhoidal disorders). Its formula was later improved, and it is still widely used today.
●Its gentle laxative action regulates bowel movements.
●It is effective for hemorrhoids, anal fissures, and mild anal prolapse in persons with moderate or greater physical strength who have hard stools and a tendency toward constipation.
Deviating from the specified dosage and administration of a medicine can lead to serious harm to health. Always read the product instructions carefully before use and follow the dosage and administration. Even when a medicine is used correctly according to the dosage and administration, side effects may occur. If you notice anything unusual, stop use immediately and consult a doctor or pharmacist.

About the Sale of Medicines

●Precautions for Use
■■Things You Must Not Do■■ (If these are not observed, current symptoms may worsen or side effects may be more likely to occur.)
1. While taking this medicine, do not take the following medicines: other laxatives
2. Persons who are breastfeeding should not take this medicine, or should avoid breastfeeding if taking this medicine.
■■Things To Consult On■■
1. The following persons should consult a doctor, pharmacist, or registered salesclerk before taking this medicine.
(1) Persons receiving treatment from a doctor
(2) Persons who are pregnant or who think they may be pregnant
(3) Persons with a weak constitution (persons whose physical strength has declined, persons with a weak body)
(4) Persons with weak stomachs and intestines who are prone to diarrhea
(5) Elderly persons
(6) Persons who have ever had rash/redness, itching, etc. caused by medicines, etc.
(7) Persons with the following symptom
Swelling (edema)
(8) Persons who have received the following diagnoses: high blood pressure, heart disease, kidney disease
2. If any of the following symptoms appear after taking this medicine, they may be side effects. Stop taking it immediately and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.

Relevant Area – Symptoms
Skin – Rash/redness, itching
Digestive system – Nausea/vomiting, loss of appetite, diarrhea accompanied by severe abdominal pain, abdominal pain

The following serious symptoms may occur rarely.
In that case, seek medical attention from a doctor immediately.

Symptom Name – Symptoms
Interstitial pneumonia – Shortness of breath or difficulty breathing when climbing stairs or exerting yourself slightly,
dry cough, fever, etc. appear suddenly or persist.

Pseudoaldosteronism, myopathy – In addition to heaviness, numbness, a feeling of tightness, and
stiffness in the hands and feet, weakness and muscle pain appear and gradually become stronger.

Liver dysfunction – Fever, itching, rash, jaundice (yellowing of the skin and the whites of the eyes), brown urine,
general fatigue, loss of appetite, etc. appear.

3. The following symptom may appear after taking this medicine. If it persists or worsens, stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.
Diarrhea

4. If symptoms do not improve after taking this medicine for about 1 month (5 to 6 days when taking it for anal fissures or constipation), stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.

5. If you are going to use this medicine continuously for a long period, consult a doctor, pharmacist, or registered salesclerk.


●Indications
For the following symptoms in persons with moderate or greater physical strength who have hard stools and a tendency toward constipation:
hemorrhoids (piles), anal fissures, constipation, mild anal prolapse


●Dosage and Administration
Take the following dose 3 times a day before meals or between meals with water or warm water.
Age – Single dose – Times per day
Adults (15 years and older) – 4 tablets – 3 times
7 years to under 15 years – 3 tablets – 3 times
5 years to under 7 years – 2 tablets – 3 times
Under 5 years – Do not take.

<Precautions related to dosage and administration> When giving this medicine to a child, do so under the guidance and supervision of a parent or guardian.


●Ingredients and Amounts
The adult daily dose of 12 tablets (1 tablet: 380 mg) contains the following ingredient.
Ingredient – Amount
Otsujito extract (3/5 amount) (extracted from 3.6 g of Japanese Angelica Root, 3.0 g of Bupleurum Root, 1.8 g of Scutellaria Root,
1.2 g of Glycyrrhiza, 0.9 g of Cimicifuga Rhizome, and 0.6 g of Rhubarb) – 2520 mg

Additives: cellulose, silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate

<Precautions related to ingredients> Because this medicine uses extracts of natural products (crude drugs), the color of the tablets may vary slightly.


●Precautions for Storage and Handling
(1) Store tightly closed in a cool place with low humidity, away from direct sunlight.
(2) Store out of the reach of children.
(3) Do not transfer to another container.
(This may cause misuse or change the quality.)
(4) The packing material in the bottle is to prevent the tablets from breaking during transport.
It is no longer needed after opening, so please discard it.
(5) Do not take the product after the expiration date.
(6) If moisture gets on the tablets, discoloration or uneven color may occur. Do not accidentally drip water on them or touch them with wet hands.


●Contact Information
If you have any questions about this medicine, please contact the store where you purchased it or the following.
Kracie Pharma, Ltd. Customer Consultation Desk
東京都港区海岸3-20-20(〒108-8080)
Phone (03)5446-3334
Hours: 10:00 to 17:00 (excluding Saturdays, Sundays, and public holidays)


Manufacturer and Distributor
Kracie Pharmaceutical, Ltd.
東京都港区海岸3-20-20(〒108-8080)

Contact for the Relief System for Sufferers from Adverse Drug Reactions: Pharmaceuticals and Medical Devices Agency (PMDA) 0120-149-931