第一三共ヘルスケア 新ルルAゴールドDXα

Features

●This is a comprehensive cold medicine that is highly effective against all 11 symptoms of a severe cold.
Can be taken by the whole family (ages 7 and over).
●The anti-inflammatory ingredient [tranexamic acid] and the antipyretic and analgesic ingredient [acetaminophen] have excellent effects on sore throat and fever.
●The sustained-release antihistamine ingredient [clemastine fumarate] and the parasympathetic nerve blocking ingredient [belladonna total alkaloids] provide a double effect against runny and stuffy nose.
The expectorant ingredient [bromhexine hydrochloride] makes it easier to expel phlegm that causes coughing.
●These are small, sugar-coated tablets with no bitterness that are easy to take even for those who don't like taking medicines.

[Designated Category 2 OTC drug]

Efficacy and effectiveness

Relief of cold symptoms (sore throat, fever, runny nose, stuffy nose, cough, phlegm, chills, headache, sneezing, joint pain, muscle pain)

<Notes regarding efficacy and effectiveness>

Dosage and Administration

Take the following amount with water or lukewarm water.
[Age: Single dose: Number of times per day]
Adults (15 years and over): 3 tablets, 3 times a day. Take within 30 minutes of a meal.
Children aged 11 to 15 years: 2 tablets, 3 times a day. Take within 30 minutes of a meal.
Children aged 7 to 11 years: 1 tablet, 3 times a day. Take within 30 minutes of a meal.
Under 7 years old: Do not take.

<Caution regarding usage and dosage>

(1) Please strictly follow the usage and dosage instructions.
(2) If you are giving this medicine to a child aged 7 or older, please have them take it under the guidance and supervision of a parent or guardian.

Ingredients and quantities

In 9 tablets <br>Clemastine fumarate 1.34mg
Belladonna total alkaloids 0.3mg
Bromhexine hydrochloride 12mg
Tranexamic acid 420mg
Acetaminophen 900mg
dl-Methylephedrine hydrochloride 60mg
Dextromethorphan hydrobromide hydrate 48mg
Caffeine anhydrous 60mg

[Additives]

Cellulose, carmellose calcium (CMC-Ca), hydroxypropyl cellulose, magnesium stearate, hypromellose (hydroxypropyl methylcellulose), macrogol, titanium oxide, white sugar, polyvinyl alcohol (partially saponified), talc, calcium carbonate, carnauba wax

<Notes regarding ingredients and quantities>

Dosage form

Sugar-coated tablets (oral tablets)

Usage notes

■Things you shouldn't do (If you do not follow these instructions, your current symptoms may worsen, or you may be more susceptible to side effects or accidents.)
1. Do not take this medicine if you are:
(1) People who have experienced allergic symptoms due to this drug or its ingredients. (2) People who have experienced asthma after taking this drug or other cold medicines or antipyretics and analgesics
2. Do not use any of the following medicines while taking this drug.
Other cold medicines, antipyretics, analgesics, sedatives, antitussives, expectorants, oral medications containing antihistamines (oral medications for rhinitis, motion sickness medications, allergy medications, etc.), gastrointestinal analgesics and antispasmodics, oral medications containing tranexamic acid
3. After taking this medicine, do not drive or operate machinery.
(Symptoms such as drowsiness, blurred vision, and abnormal glare may occur.)
4. Do not drink alcohol before or after taking this medicine.
5. Do not use for extended periods.
■Things to consult about
1. The following people should consult a doctor, pharmacist, or registered distributor before taking this medicine.
(1) People receiving treatment from a doctor or dentist (2) Pregnant women or those suspected to be pregnant (3) People who are breastfeeding (4) Elderly people (5) People who have experienced allergic symptoms due to medicine, etc. (6) People with the following symptoms: high fever, difficulty urinating (7) Those who have been diagnosed with the following: thyroid disorder, diabetes, heart disease, high blood pressure, liver disease, kidney disease, gastric or duodenal ulcers, glaucoma, those with blood clots (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.), and those at risk of developing thrombosis.
2. If the following symptoms are observed after taking this medicine, these may be side effects, so stop taking the medicine immediately and consult a doctor, pharmacist, or registered distributor with this leaflet.
[Affected area: Symptoms]
Skin: rash, redness, itching <br>Digestive system: Nausea, vomiting, loss of appetite <br>Nervous system: dizziness, excitement, convulsions, headache
Respiratory: Shortness of breath, difficulty breathing <br>Urinary system: Difficulty urinating <br>Other: Excessive drop in body temperature, hot flashes on the face, abnormal glare In rare cases, the following serious symptoms may occur. If this occurs, consult a doctor immediately.
[Name of symptom: Symptom]
Shock (anaphylaxis): Immediately after taking the medicine, symptoms may include itchy skin, hives, hoarseness, sneezing, itchy throat, shortness of breath, palpitations, and confusion.
Stevens-Johnson syndrome: High fever, bloodshot eyes, eye discharge, sores on the lips, sore throat, widespread skin rash and redness, small bumps (pustules) on the red skin, general fatigue, loss of appetite, etc. may persist or suddenly worsen.
Toxic epidermal necrolysis: High fever, bloodshot eyes, eye discharge, sores on the lips, sore throat, widespread skin rash and redness, small bumps (pustules) on the red skin, general fatigue, loss of appetite, etc. may persist or suddenly worsen.
Acute generalized exanthematous pustulosis: High fever, bloodshot eyes, eye discharge, sores on the lips, sore throat, widespread rash and redness on the skin, small bumps (pustules) on the red skin, general fatigue, loss of appetite, etc. may persist or suddenly worsen.
Drug hypersensitivity syndrome: Symptoms include widespread redness of the skin, generalized rash, fever, fatigue, and swelling of the lymph nodes (neck, armpits, groin, etc.).
Liver dysfunction: Symptoms include fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), brown urine, general fatigue, and loss of appetite.
Kidney damage: Symptoms include fever, rash, decreased urine output, generalized swelling, general fatigue, joint pain (pain in the joints), and diarrhea.
Interstitial pneumonia: When climbing stairs or exerting yourself slightly, you may experience shortness of breath, difficulty breathing, dry cough, fever, etc. These symptoms may appear suddenly or persist.
Asthma: Symptoms include wheezing, shortness of breath, etc.
3. The following symptoms may occur after taking this medicine. If these symptoms persist or worsen, discontinue use and consult a doctor, pharmacist, or registered distributor with this leaflet.
Constipation, dry mouth, drowsiness, blurred vision
4.If symptoms do not improve after taking the medicine 5 to 6 times, stop taking the medicine and consult a doctor, pharmacist, or registered distributor with this leaflet.

Storage and handling precautions

(1) Store the product tightly sealed in a cool, dry place away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to other containers. (This may cause misuse or change the quality.)
(4) Do not handle with wet hands. If moisture comes into contact with the tablets, part of the surface may dissolve, causing discoloration or uneven coloring. Also, do not return wet tablets to the bottle, as this will affect the other tablets.
(5) The filling material inside the bottle is used to protect the tablets from damage during transport. Please discard it after opening.
(6) Do not use the product after the expiration date. After opening the bottle, use the product within 12 months.
(7) Please write the date you opened the bottle in the “Date of Opening” section on the box.