Product Overview
Manufacturer: Kracie Pharmaceuticals
Product Name: "Kracie" Kampo Otsuji-to Extract Tablets 180 Tablets
Medical Drug Classification: Class 2 OTC Drug
Category: OTC Medicine
Pediatric Use Category: Suitable for children and adults
Dosage Form: Tablets, round tablets, capsules
Contents: 180 tablets
Product Description: Kampo (traditional Japanese herbal medicine) formulation

【Expiration Date】
At the time of shipment, the product has at least one year remaining before expiration.
JAN Code: 4987045109164
Product Code: 076008201

■ Date of Initial Package Insert Creation and Revision, Version of Package Insert
Initial Creation: August 2020
Revised: None
Version: TS01
Please be sure to read this instruction leaflet before use.
Keep it in a safe place so you can refer to it when needed.

■ Features
● "Otsuji-to" was created during the Edo period by the renowned medical scholar Hara Nanyo as a specialized herbal prescription for "disease of the urethra," and it has been widely used since then after modifications to its formulation.
● It promotes gentle bowel movements, regulating stool passage.
● Effective for hemorrhoids, anal fissures, and mild prolapse in individuals with moderate or higher physical strength, hard stools, and tendencies toward constipation.

■ Do Not Do
(If not followed, current symptoms may worsen or side effects may become more likely)

1. Do not take other laxatives (purgatives) while taking this product.
2. Pregnant or breastfeeding women should not take this product, or if they do, should avoid breastfeeding.

■ Consult Before Use
1. Consult a doctor, pharmacist, or registered salesperson before use if you are:
(1) Under medical treatment
(2) Pregnant or suspect pregnancy
(3) Physically weak (lacking strength or frail)
(4) Have a weak stomach or tend to diarrhea
(5) Elderly
(6) Have experienced rashes, redness, itching, etc., from medications before
(7) Have symptoms such as swelling
(8) Diagnosed with hypertension, heart disease, or kidney disease
2. If any of the following symptoms appear after taking the product, discontinue immediately and consult a doctor, pharmacist, or registered salesperson with this leaflet, as side effects may be present:
- Skin: Rash, redness, itching
- Digestive system: Nausea, vomiting, loss of appetite, severe diarrhea with abdominal pain, abdominal pain
Rarely, serious symptoms such as the following may occur. Seek medical attention immediately if they appear:
- Interstitial pneumonia: Shortness of breath or difficulty breathing when climbing stairs or exerting oneself, cough, fever, etc., appearing suddenly or persisting.
- Pseudoaldosteronism, myopathy: Weakness, numbness, stiffness, or rigidity in limbs, along with fatigue and muscle pain, gradually worsening.
- Liver dysfunction: Fever, itching, rash, jaundice (yellowing of skin and whites of eyes), dark urine, general fatigue, loss of appetite.
3. After taking the product, symptoms such as diarrhea may occur. If these symptoms persist or worsen, stop taking the product and consult a healthcare professional with this leaflet.
4. If symptoms do not improve after about one month (or 5-6 days for hemorrhoids or constipation), discontinue use and consult a healthcare professional with this leaflet.
5. For long-term use, consult a healthcare professional, pharmacist, or registered salesperson.

■ Indications and Effects
For individuals with moderate or higher physical strength, hard stools, and tendencies toward constipation, the following conditions:
- Hemorrhoids (piles)
- Anal fissures
- Constipation
- Mild prolapse

■ Usage and Dosage
Take the following amount three times daily before meals or between meals with water or warm water.

| Age | Single Dose | Daily Frequency |
|---|---|---|
| Adults (15 years and older) | 4 tablets | 3 times |
| 7 to under 15 years | 3 tablets | 3 times |
| 5 to under 7 years | 2 tablets | 3 times |
| Under 5 years | Do not use |

For children, use under the supervision and guidance of a guardian.

■ Ingredients and Amounts
In 12 tablets (total daily dose for adults, 380 mg per tablet, totaling 4,560 mg):
- Otsuji-to extract (3/5 quantity) (Angelica root 3.6 g, Bupleurum 3.0 g, Scutellaria 1.8 g, Licorice 1.2 g, Cimicifuga 0.9 g, Rhei 0.6 g extracted) — 2,520 mg

Additives include cellulose, silicon dioxide, cross-linked sodium carboxymethyl cellulose (CMC-Na), crosspovidone, and magnesium stearate.

Since this product uses natural (herbal) extracts, the color of the tablets may vary slightly.

■ Storage and Handling Precautions
(1) Store in a cool, dry place away from direct sunlight, tightly sealed.
(2) Keep out of reach of children.
(3) Do not transfer to other containers. Doing so may cause misuse or change in quality.
(4) The packing material inside the bottle is to prevent tablet breakage during transport. Discard after opening.
(5) Do not take products past the expiration date.
(6) Moisture can cause discoloration or uneven coloring of the tablets. Do not accidentally drop water droplets on the tablets or handle with wet hands.

■ Contact
If you notice anything concerning about this product, please contact the store where you purchased it or the following:
Kracie Pharmaceuticals Customer Service Center
Address: 3-20-20 Kaigan, Minato-ku, Tokyo 108-8080
Phone: (03) 5446-3334
Hours: 10:00–17:00 (excluding Saturdays, Sundays, and holidays)
Website: www.kracie.co.jp

■ Manufacturer
Kracie Pharmaceuticals

■ Contents
180 tablets

■ Suggested Retail Price
4,180 yen (tax included)

■ OTC Drug Classification
Class 2 OTC drug

■ Poison and Quasi-Drug Category
Not classified as poison or quasi-drug

■ Pesticide/Animal Drug Category
Not classified as pesticide or animal drug

■ Dosage Form Category
Tablet

■ Pediatric Use Category
Suitable for children and adults

■ Product Category
OTC medicine

■ Disclaimer
【Notice】
- The product descriptions above, excluding pricing information, are provided by the manufacturer or the Self-Medication Data Center.
- If you have any questions or concerns about using this medicine, be sure to consult a doctor or pharmacist.
- We assume no responsibility for health damages resulting from the use of medicines purchased through this service.