New Lulu A Gold DXα 60 Tablets [Designated Class 2 OTC Drug]

Product Information

Combination cold medicine
For sore throat, fever, runny nose, nasal congestion, cough, and phlegm

●A combination cold medicine that is highly effective against all 11 troublesome symptoms of a cold.
It can be taken by the whole family. (7 years and older)
●The actions of the anti-inflammatory ingredient [tranexamic acid] and the antipyretic analgesic ingredient [acetaminophen] provide excellent effectiveness against sore throat and fever.
●The long-acting antihistamine ingredient [clemastine fumarate] and the parasympatholytic ingredient [belladonna total alkaloids] work doubly against runny nose and nasal congestion.
●The expectorant ingredient [bromhexine hydrochloride] makes it easier to cough up the phlegm that causes coughing.
●Small sugar-coated tablets with no bitter taste that are easy to take even for those who dislike taking medicine.

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■■ (If you do not follow these, your current symptoms may worsen, or side effects or accidents may be more likely to occur)
1. The following persons must not take this medicine.
(1) Persons who have had allergic symptoms caused by this medicine or any of its ingredients
(2) Persons who have had asthma after taking this medicine or other cold medicines or antipyretic analgesics
2. While taking this medicine, do not use any of the following medicines.
Other cold medicines, antipyretic analgesics, sedatives, antitussive and expectorants, oral medicines containing antihistamines, etc. (oral medicines for rhinitis, motion sickness medicines, allergy medicines, etc.), gastrointestinal analgesic and antispasmodic medicines, oral medicines containing tranexamic acid
3. Do not drive a vehicle or operate machinery after taking this medicine.
(Symptoms such as drowsiness, blurred vision, or abnormal sensitivity to light may occur)
4. Do not drink alcohol before or after taking this medicine.
5. Do not use continuously for a long period.
■■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 or dentist
(2) Persons who are pregnant or who think they may be pregnant
(3) Persons who are breastfeeding
(4) Elderly persons
(5) Persons who have had allergic symptoms caused by medicines, etc.
(6) Persons with the following symptoms
High fever, difficulty urinating
(7) Persons who have received the following diagnoses: thyroid dysfunction, diabetes, heart disease, high blood pressure, liver disease, kidney disease, gastric or duodenal ulcer, glaucoma; persons with blood clots (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.), persons at risk of developing thrombosis
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 this document with you.

Relevant Area – Symptoms
Skin – Rash/redness, itching
Digestive system – Nausea/vomiting, loss of appetite
Psychiatric/nervous system – Dizziness, excitement, convulsions, headache
Respiratory system – Shortness of breath, difficulty breathing
Urinary system – Difficulty urinating
Other – Excessive drop in body temperature, facial flushing, abnormal sensitivity to light

The following serious symptoms may occur rarely.
In that case, see a doctor immediately.

Symptom Name – Symptoms
Shock (anaphylaxis) – Immediately after taking the medicine, itching of the skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.

Oculomucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustulosis – High fever, red eyes, eye discharge, sores on the lips, sore throat, widespread rash/redness of the skin, small bumps (small pustules) on reddened skin, general fatigue, loss of appetite, etc. persist or rapidly worsen.

Drug-induced hypersensitivity syndrome – Widespread reddening of the skin, generalized rash, fever, fatigue, swelling of the lymph nodes (neck, armpits, groin, etc.), etc. appear.

Liver dysfunction – Fever, itching, rash, jaundice (yellowing of the skin and the whites of the eyes), brown urine, general fatigue, loss of appetite, etc. appear.

Kidney damage – Fever, rash, decreased urine output, swelling of the whole body, general fatigue, joint pain (aching joints), diarrhea, etc. appear.

Interstitial pneumonia – Shortness of breath or difficulty breathing when climbing stairs or exerting yourself a little, dry cough, fever, etc. are seen, and these appear suddenly or persist.

Asthma – Wheezing or whistling sounds when breathing, difficulty breathing, etc. appear.

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 this document with you.
Constipation, dry mouth, drowsiness, blurred vision

4. If symptoms do not improve after taking this medicine 5 to 6 times, stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing this document with you.



●Indications
Relief of the various symptoms of a cold (sore throat, fever, runny nose, nasal congestion, cough, phlegm, chills, headache, sneezing, joint pain, muscle pain)



●Dosage and Administration
Take the following dose with water or hot water.
Age – Single dose – Times per day
Adults (15 years and older) – 3 tablets – 3 times; take preferably within 30 minutes after a meal.
11 years to under 15 years – 2 tablets – 3 times; take preferably within 30 minutes after a meal.
7 years to under 11 years – 1 tablet – 3 times; take preferably within 30 minutes after a meal.
Under 7 years – Do not take.

<Precautions related to dosage and administration>
(1) Strictly follow the dosage and administration.
(2) When having a child 7 years or older take this medicine, do so under the guidance and supervision of a parent or guardian.



●Ingredients and Amounts
This medicine is a white sugar-coated tablet, and 9 tablets contain the following ingredients.
Ingredient – Amount – Action
Clemastine fumarate – 1.34 mg
– Continuously suppresses the allergic symptoms of a cold (runny nose, sneezing, etc.).

Belladonna total alkaloids – 0.3 mg
– Suppresses runny nose.

Bromhexine hydrochloride – 12 mg
– Makes it easier to cough up phlegm, one of the causes of coughing.

Tranexamic acid – 420 mg
– Suppresses [plasmin], the source of inflammation, and relieves swelling and pain in the throat.

Acetaminophen – 900 mg
– Lowers fever and relieves headache and joint pain.

dl-Methylephedrine hydrochloride – 60 mg
– Widens the bronchi and calms coughs.

Dextromethorphan hydrobromide hydrate – 48 mg
– Acts on the cough center to calm coughs.

Anhydrous caffeine – 60 mg
– Relieves headache.

Additives: cellulose, carmellose calcium, hydroxypropylcellulose, magnesium stearate, hypromellose, macrogol, titanium oxide, sucrose, polyvinyl alcohol (partially hydrolyzed), talc, calcium carbonate, carnauba wax



●Precautions for Storage and Handling
(1) Store tightly closed 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 handle with wet hands.
If moisture gets on the tablets, part of the surface may dissolve, causing discoloration or uneven color.
Also, do not put wet tablets back into the bottle, as this will affect the other tablets.
(5) The packing material in the bottle is to prevent the tablets from breaking during transport. Discard it after opening.
(6) Do not use the product after the expiration date shown on the label.
Also, use within 12 months after opening the bottle.
(7) Write the date you opened the bottle in the "Date opened" field on the box.

[Other information in the package insert] What causes a cold?
A cold is an "acute inflammatory disease of the upper respiratory tract," such as the "throat" and "nose."
Viruses, etc. enter the body through the throat, nose, etc. and trigger an excessive inflammatory response.
This inflammatory response causes respiratory symptoms such as sore throat, runny nose, cough, and phlegm, as well as fever and other symptoms.
The key to relieving cold symptoms is first to control and calm the inflammation.



●Contact Information
For inquiries about this product, please contact the store where you purchased it or the following.
Daiichi Sankyo Healthcare Co., Ltd. Customer Consultation Office
〒103-8234 東京都中央区日本橋3-14-10
Tel. 0120-337-336
Hours: 9:00 to 17:00 (excluding Saturdays, Sundays, and public holidays)
For more information about Lulu

Manufacturer and Distributor
Daiichi Sankyo Healthcare Co., Ltd.
東京都中央区日本橋3-14-10
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