Designated Class 2 OTC DrugOral medicine—Tablets
Haiyasumin A
For relief of temporary insomnia symptoms involving difficulty falling asleep or shallow sleep
✦ Diphenhydramine hydrochloride✦ Once daily before bedtime✦ For temporary insomnia
For whom and when
🌙
When you have difficulty falling asleep
For those who cannot fall asleep easily and feel they are temporarily having difficulty falling asleep
💤
When your sleep is shallow
For those who want to relieve temporary insomnia symptoms involving shallow sleep
🛏️
When you want to be prepared for bedtime
For those who want to address temporary insomnia symptoms by taking this product before bedtime
⚠️
For those who can follow the directions not to use continuously
For those who can limit use to times when they have difficulty falling asleep or shallow sleep
Product overview
Haiyasumin A is a medicine used to relieve temporary insomnia symptoms such as difficulty falling asleep and shallow sleep. The active ingredient, diphenhydramine hydrochloride, has been used to relieve allergy symptoms, but it also causes drowsiness when taken. This product focuses on this effect and produces drowsiness by suppressing the action of histamine in the brain, which is involved in maintaining and regulating wakefulness.
Product features
01
Focused on temporary insomnia symptoms
Indications
This formulation is intended to relieve temporary insomnia symptoms such as difficulty falling asleep and shallow sleep.
02
Utilizes an antihistamine effect
Ingredients
The active ingredient diphenhydramine hydrochloride suppresses the action of histamine, which is involved in maintaining and regulating wakefulness, producing a drowsiness-inducing effect.
03
Designed for once-daily use before bedtime
Dosage
Take once before bedtime when you have difficulty falling asleep or shallow sleep. Do not take except before bedtime.
✦
Single active ingredient
A formulation containing diphenhydramine hydrochloride as the active ingredient
✦
Film-coated tablet
These are Tablets that can be taken without chewing
Indications
Relief of the following symptoms of temporary insomnia: difficulty falling asleep, shallow sleep
Directions and dosage
| Age |
Dose per occasion |
Number of doses per day |
| Adults (15 years and older) |
2 Tablets |
Once daily, before bedtime |
| Under 15 years of age |
Do not take |
— |
Take this product when you have difficulty falling asleep or shallow sleep. Strictly follow the specified dosage and directions. Taking more than 2 Tablets at one time may cause unpleasant symptoms such as heightened nervousness and may make it difficult to sleep. Do not take this product except before bedtime. Remove the Tablets from the PTP sheet before taking them.
⚠️ Precautions for use
- The following people should not take this product: (1) pregnant people or those who may be pregnant (2) children under 15 years of age (3) people who routinely suffer from insomnia (4) people diagnosed with insomnia
- While taking this product, do not use other oral medicines containing hypnotic sedatives, cold medicines, antipyretic analgesics, cough suppressants or expectorants, antihistamines, etc. (including oral medicines for rhinitis, motion sickness medicines, and allergy medicines)
- Do not drive vehicles or operate machinery after taking this product (drowsiness may cause an accident. If drowsiness or fatigue continues until the next day, do not drive or operate machinery until the symptoms have disappeared)
- People who are breastfeeding should not take this product; if they do, they should avoid breastfeeding
- Do not drink alcohol before or after taking this product
- Use only when you have difficulty falling asleep or shallow sleep, and do not use continuously
- The following people should consult a doctor, pharmacist, or registered salesperson before taking this product: people receiving medical treatment, Elderly, people who have experienced allergic symptoms caused by medicines or other substances, people who have difficulty urinating, and people diagnosed with glaucoma or an enlarged prostate
- If any of the following symptoms occur after taking this product—skin rash, redness or itching, stomach pain, nausea or vomiting, loss of appetite, dizziness, headache, a heavy-headed feeling upon waking, daytime drowsiness, feeling unwell, nervousness, temporary impaired consciousness, palpitations, difficulty urinating, or fatigue—stop taking it immediately and consult a doctor, pharmacist, or registered salesperson
- If dry mouth occurs, or diarrhea persists or worsens, stop taking this product and consult a doctor, pharmacist, or registered salesperson
- If symptoms do not improve after taking 2–3 doses, stop taking this product and consult a doctor, pharmacist, or registered salesperson
- Drowsiness or fatigue may persist until the next day
📦 Storage precautions
- Store in a cool, low-humidity place away from direct sunlight
- Store out of the reach of children
- Do not transfer the product to another container (this may cause misuse or alter the quality)
- Do not use the product after its expiration date
● Features
Characteristics of Haiyasumin A
Haiyasumin A is a medicine effective for alleviating temporary insomnia symptoms such as difficulty falling asleep and light sleep. The active ingredient of Haiyasumin A, diphenhydramine hydrochloride, has generally been used to relieve allergy symptoms such as skin itching, sneezing, and runny nose, but it also has the effect of causing drowsiness when taken. Haiyasumin A was developed focusing on this drowsiness-inducing effect.
How Haiyasumin A works
Histamine is one of the components involved in maintaining and regulating wakefulness in the brain. The active ingredient of Haiyasumin A, diphenhydramine hydrochloride, expresses a sleep-inducing effect by suppressing the action of this histamine.
【Designated Class 2 OTC Drug】
●Efficacy/Effects
Alleviation of the following symptoms of temporary insomnia: difficulty falling asleep, light sleep
<Precautions related to Efficacy/Effects>
●Dosage and Administration
When you have difficulty falling asleep or light sleep, take the following single dose once a day before bedtime.
[Age: Single dose]
Adults (15 years and older): 2 tablets
Under 15 years: Do not take
<Precautions related to Dosage and Administration>
(1) Strictly follow the prescribed dosage and administration.
(2) Taking more than 2 tablets at one time may cause unpleasant symptoms such as nervousness and may actually prevent sleep.
(3) Do not take except before bedtime.
(4) How to remove tablets
Press strongly on the raised part of the PTP sheet containing the tablets with your fingertip to break the aluminum foil on the back, then take out the tablet before taking it. (Swallowing it as is by mistake may cause unexpected accidents such as piercing the esophageal mucosa.)
●Ingredients/Quantity
Per 2 tablets
Diphenhydramine hydrochloride 50 mg
〔Additives〕
Cellulose, lactose, carmellose calcium (CMC-Ca), magnesium stearate, hypromellose (hydroxypropyl methylcellulose), titanium oxide, macrogol, carnauba wax
<Precautions related to Ingredients/Quantity>
●Dosage Form
Tablets (oral tablets)
●Precautions for Use
■Do not do (Contraindications)
(If not followed, current symptoms may worsen or side effects/accidents may occur more easily)
1. Do not take if you are:
(1) Pregnant or suspected to be pregnant.
(2) A child under 15 years old.
(3) Suffering from chronic insomnia.
(4) Diagnosed with insomnia.
2. Do not use any of the following medicines while taking this product:
Other hypnotic sedatives, cold medicines, antipyretic analgesics, cough expectorants, oral medicines containing antihistamines (oral medicines for rhinitis, motion sickness medicines, allergy medicines, etc.)
3. Do not drive vehicles or operate machinery after taking this medicine
(It may cause drowsiness and lead to accidents. Also, if drowsiness or fatigue continues until the next day after taking this medicine, do not drive vehicles or operate machinery until these symptoms disappear.)
4. Nursing mothers should either avoid taking this medicine or avoid breastfeeding while taking it.
5. Do not drink alcohol before or after taking this medicine.
6. Limit use to times when you have difficulty falling asleep or light sleep; do not use continuously.
■Consult
1. Consult a doctor, pharmacist, or registered seller before taking if you:
(1) Are receiving medical treatment.
(2) Are elderly.
(In elderly people, drowsiness may be strong or, conversely, symptoms such as nervousness may appear.)
(3) Have had allergic reactions to medicines.
(4) Have the following symptoms:
Difficulty urinating
(5) Have been diagnosed with:
Glaucoma, prostatic hypertrophy
2. If the following symptoms appear after taking, they may be side effects; stop taking immediately and consult a doctor, pharmacist, or registered seller with this document.
[Affected area: Symptoms]
Skin: rash, redness, itching
Digestive system: stomach pain, nausea/vomiting, loss of appetite
Neuropsychiatric system: dizziness, headache, heavy head upon waking, daytime drowsiness, discomfort, nervousness, temporary consciousness disorder (decreased attention, drowsy-like symptoms, impaired judgment, abnormal behavior, etc.)
Circulatory system: palpitations
Urinary system: difficulty urinating
Others: fatigue
3. The following symptoms may appear after taking; if these symptoms persist or worsen, stop taking and consult a doctor, pharmacist, or registered seller with this document:
Dry mouth, diarrhea
4. If symptoms do not improve after 2 to 3 doses, stop taking and consult a doctor, pharmacist, or registered seller with this document.
■Other precautions
Drowsiness or fatigue may continue until the next day.
●Precautions for Storage and Handling
(1) Store in a cool place with little humidity, away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to other containers. (This may cause misuse or quality changes.)
(4) Do not take products past their expiration date.