
Drewell 12 Tablets [Designated Class 2 OTC Drug]
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Product Description
Product Information
Sleep aid
Relief of the following symptoms of temporary insomnia: difficulty falling asleep, light sleep
●For temporary insomnia in situations and people like these
○Cannot sleep due to a lot of stress
○Tired but too wound up to fall asleep
○Wake up in the middle of the night because of worries
○Sleep rhythm disrupted by an irregular lifestyle, making it hard to fall asleep. Taken before bedtime, Drewell works to relieve symptoms of temporary insomnia such as difficulty falling asleep and light sleep.
●The active ingredient of Drewell
The active ingredient of Drewell (diphenhydramine hydrochloride) is widely used to soothe itchy skin and to suppress allergic symptoms such as sneezing and runny nose, but it also has the effect of causing drowsiness when taken.
Drewell is a medicine made by applying this drowsiness-inducing effect of diphenhydramine hydrochloride.
●How Drewell makes you sleepy: In the posterior hypothalamus, which is closely involved in sleep and wakefulness in the brain, there are many histamine neurons, which are known as excitatory neurons. Histamine released from their terminals maintains and regulates wakefulness by exciting nerve cells in various parts of the brain, including the cerebral cortex. The active ingredient of Drewell (diphenhydramine hydrochloride) suppresses the action of histamine in the brain, producing a sleep-inducing effect.
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■■ (Failure to follow these may worsen current symptoms or make side effects and accidents more likely to occur.)
1. The following persons must not take this medicine.
(1) Persons who are pregnant or who think they may be pregnant.
(2) Children under 15 years.
(3) Persons who suffer from insomnia on a daily basis.
(4) Persons who have been diagnosed with insomnia.
2. While taking this medicine, do not use any of the following medicines: other hypnotic sedatives, cold medicines, antipyretic analgesics, antitussive and expectorant medicines, oral medicines containing antihistamines, etc. (oral medicines for rhinitis, motion sickness medicines, allergy medicines, etc.)
3. After taking this medicine, do not drive a vehicle or operate machinery. (It may cause drowsiness and lead to accidents. Also, if drowsiness continues or you feel sluggish until the next day after taking this medicine, do not drive a vehicle or operate machinery until these symptoms disappear.)
4. Persons who are breastfeeding should not take this medicine, or should avoid breastfeeding if taking this medicine.
5. Do not drink alcohol before or after taking this medicine.
6. Take this medicine only when you have difficulty falling asleep or are sleeping lightly, and do not use it continuously.
■■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) Elderly persons. (In elderly persons, drowsiness may appear strongly, or conversely, symptoms such as nervous excitement may appear.)
(3) Persons who have had allergic symptoms caused by medicines, etc.
(4) Persons with the following symptom.
Difficulty urinating
(5) Persons who have received the following diagnoses.
Glaucoma, enlarged prostate
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 these instructions with you. [Relevant Area] [Symptoms] Skin: Rash/redness, itching Digestive system: Stomach pain, nausea/vomiting, loss of appetite Psychiatric/nervous system: Dizziness, headache, heavy-headed feeling on waking, daytime drowsiness, feeling unwell, nervousness, temporary impairment of consciousness (reduced attention, half-asleep-like state, impaired judgment, abnormal speech or behavior, etc.)
Circulatory system: Palpitations
Urinary system: Difficulty urinating Other: Fatigue
3. The following symptoms may appear after taking this medicine. If they persist or worsen, stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing these instructions with you.
Dry mouth, diarrhea
4. If symptoms do not improve after taking this medicine 2 to 3 times, stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing these instructions with you.
Other precautions
Drowsiness may continue or you may feel sluggish until the next day.
●Indications
Relief of the following symptoms of temporary insomnia: difficulty falling asleep, light sleep
●Dosage and Administration
When you have difficulty falling asleep or are sleeping lightly, take the following single dose once a day before bedtime with water or lukewarm water.
[Age] Adults (15 years and older)
[Single dose] 2 tablets
[Age] Under 15 years [Single dose] Do not take.
<Precautions related to dosage and administration>
(1) Strictly follow the dosage and administration.
(2) Taking more than 2 tablets at a time may cause unpleasant symptoms such as nervous excitement and may instead make you unable to sleep.
(3) Do not take this medicine except before bedtime.
(4) How to remove the tablets
Press the raised part of the PTP sheet containing the tablet firmly with your fingertip to break the aluminum foil on the back, then take out the tablet and take it. (Accidentally swallowing the tablet with the sheet may lead to unexpected accidents, such as the sheet piercing the esophageal mucosa.)
●Ingredients and Amounts
In 2 tablets
Diphenhydramine hydrochloride – 50 mg
Additives: croscarmellose sodium, light anhydrous silicic acid, cellulose, lactose, hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, talc, titanium oxide
●Precautions for Storage and Handling
(1) Store 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) Do not take the product after the expiration date.
●Contact Information
Please contact the store where you purchased it or the Customer Consultation Office.
SSP Co., Ltd. Customer Consultation Office
〒163-1488 東京都新宿区西新宿3-20-2
0120-028-193
From 9:00 to 17:30 (excluding Saturdays, Sundays, and public holidays)
Translation Notice
- This product is manufactured and labeled for sale and use in Japan in accordance with Japanese laws and regulations.
- This English product information is a translation of the original Japanese product information and is provided for reference only. It does not guarantee that the product or this information conforms to the laws and regulations of any country other than Japan.
- The translation may contain errors or omissions and may be revised without notice. If there is any discrepancy between this translation and the original Japanese text, the original Japanese text takes precedence. The original is available on the Japanese version of this page.