Product Overview
Manufacturer: Kracie
Product Name: Kracie Kampo Gojinshinkigan Extract Tablets 360 Tablets
Drug Classification: Class 2 OTC Drug
Category: OTC Medicine
Pediatric Use Category: Suitable for both adults and children
Dosage Form: Tablets,丸剤 (round tablets), Capsules
Contents: 360 tablets
Product Description: Effective for腰痛 (lower back pain),下肢痛 (pain in the lower limbs), and similar conditions.

【Expiration Date】
At the time of shipment, the product has at least one year remaining before the expiration date.

JAN Code: 4987045048913
Product Code: 076006671

■ Initial Creation and Revision Dates, Version of the Package Insert
Initial Creation: July 2007
Revision: March 2013
Version: TS05

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
● "Gojinshinkigan" is a traditional Chinese herbal medicine listed in the classical Chinese medical text "Jisheng Fang," specifically in the section on edema.
● It is effective for those who are easily fatigued, have cold limbs, decreased urine output, and swelling, as well as腰痛 (lower back pain) and下肢痛 (pain in the lower limbs).

■ Precautions and Consultations
1. Before taking this medicine, consult a doctor, pharmacist, or registered salesperson if you are:
(1) Under medical treatment
(2) Pregnant or suspected to be pregnant
(3) Have weak stomach or intestines and tend to have diarrhea
(4) Experience strong hot flashes, redness of the face, and have good physical strength
(5) Have previously experienced rash, redness, itching, or other allergic reactions to medicines or other products

2. If any of the following symptoms appear after taking the medicine, discontinue immediately and consult a doctor, pharmacist, or registered salesperson with this leaflet, as they may indicate side effects:
[Related parts] [Symptoms]
Skin: Rash, redness, itching
Digestive system: Loss of appetite, stomach discomfort, abdominal pain
Others: Palpitations, hot flashes, numbness of lips or tongue

Rarely, severe symptoms such as the following may occur. In such cases, seek medical attention immediately:
[Name of symptom] Interstitial pneumonia
[Symptoms] Shortness of breath or difficulty breathing when climbing stairs or exerting oneself, cough, fever, etc., appearing suddenly or persisting.

[Name of symptom] Liver dysfunction
[Symptoms] Fever, itching, rash, jaundice (yellowing of skin and whites of the eyes), dark urine, general fatigue, loss of appetite, etc.

3. After taking the medicine, the following symptoms may occur. If these symptoms persist or worsen, stop taking the medicine and consult a doctor, pharmacist, or registered salesperson with this leaflet:
Diarrhea

4. If symptoms do not improve after about one month of use, discontinue and consult a healthcare professional with this leaflet.

■ Efficacy and Effects
For individuals with moderate or less physical strength, who are easily fatigued, have cold limbs, decreased urine output, swelling, and sometimes dry mouth, the following symptoms are improved:
Lower limb pain,腰痛 (lower back pain), numbness, blurred vision in the elderly, itching, difficulty urinating, frequent urination, swelling, and associated symptoms of hypertension (such as shoulder stiffness, headache, tinnitus).

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

【Adults (15 years and older)}】
- 4 tablets per dose
- 3 times daily

【Children aged 7 to under 15】
- 3 tablets per dose
- 3 times daily

【Children aged 5 to under 7】
- 2 tablets per dose
- 3 times daily

【Children under 5】
- Do not take

＜Precautions related to usage and dosage＞
When administering to children, do so under the guidance and supervision of a guardian.

■ Ingredients and Quantities
In the adult daily dose of 12 tablets (each 319 mg), the following ingredients are included:
Gojinshinkigan extract (half the amount used in "Symptom-specific treatment") — 2,400 mg
[Extracted from: Rehmannia 2.5 g, Sanjyu (Sanzhu), Sanyaku, Takusha, Bukuryo, Botanpi, Goshitsu, Shazen-shi (each 1.5 g), Keihi 0.5 g, Bushi powder 0.25 g]

As excipients, contains silicon dioxide, cellulose, CMC-Ca, magnesium stearate, hypromellose, macrogol, titanium dioxide, caramel, and carnauba wax.

■ Storage and Handling Precautions
(1) Store in a cool, dry place away from direct sunlight.
(For bottled packaging) Keep tightly sealed. The filler inside the bottle prevents tablet breakage during transport. Discard after opening.
(2) Keep out of reach of children.
(3) Do not transfer to other containers to prevent misuse or quality deterioration.
(4) Do not use products past their expiration date.
(5) Moisture can cause discoloration or uneven coloring of tablets. Do not drop water droplets on the tablets or handle with wet hands.
(6) For 4-tablet packages, if you split the package and take remaining tablets, fold back the opening of the bag for storage. Do not use after two days.

■ Other Information in the Package Insert
[Health Advice]
● Keep warm
Pain such as腰痛 (lower back pain) can worsen due to cold or humidity. Keep warm. Warming the body in baths can help relieve pain and make joint movement easier.
● Intake of calcium
To strengthen bones and muscles, it is important to consume calcium-rich foods regularly, and to engage in sunlight exposure and exercise.

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

■ Common Product (JAN) Codes by Packaging
180 tablets: 4987045048906
360 tablets: 4987045048913

■ Manufacturer
Kracie

■ Contents
360 tablets × 1 package

■ Suggested Retail Price
6,380 yen (tax included)

■ OTC Drug Classification
Class 2 OTC Drug

■ Poisonous 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 both adults and children

■ Product Category
OTC Medicine

■ Disclaimer
【Caution】
- The product descriptions above, excluding price 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 caused by taking medicines purchased through this service.