New Lulu A Gold DXα 90 Tablets [Designated Class 2 OTC Drug]

Product Information

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

●A cold medicine that is highly effective against all 11 distressing cold symptoms.
Can be taken by the whole family. (7 years of age or older)
●Through the action of the anti-inflammatory ingredient [tranexamic acid] and the antipyretic analgesic ingredient [acetaminophen], it is highly effective against sore throat and fever.
●The long-acting antihistamine ingredient [clemastine fumarate],
and the parasympathetic blocking ingredient [belladonna total alkaloids] provide a double effect on runny nose and nasal congestion.
●The expectorant ingredient [bromhexine hydrochloride] makes it easier to expel the phlegm that causes coughing.
●Small, sugar-coated tablets with no bitter taste that are easy to take even for those who dislike medicine.

Deviating from the specified dosage and administration of a medicine leads 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.

●Precautions for Use
■■Things You Must Not Do■■
(Failure to follow these instructions may worsen current symptoms or increase the risk of side effects or accidents)
1. The following persons must not take this medicine.
(1) Persons who have had allergic symptoms caused by this medicine or its ingredients
(2) Persons who have experienced asthma after taking this medicine or other cold medicines or antipyretic analgesics
2. Do not use any of the following medicines while taking this medicine.
Other cold medicines, antipyretic analgesics, sedatives, antitussive and expectorant medicines, 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, and 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, hypertension, liver disease, kidney disease,
Gastric/duodenal ulcer, glaucoma, persons with thrombosis (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
Neuropsychiatric 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 such cases, see a doctor immediately.

Symptom Name – Symptoms
Shock (anaphylaxis) – Immediately after taking this medicine, symptoms such as itching of the skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, and clouding of consciousness may occur.

Mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustulosis – Symptoms such as high fever, bloodshot eyes, eye discharge, lip sores, sore throat, widespread skin rash/redness, small bumps (small pustules) appearing on reddened skin, general fatigue, and loss of appetite may persist or suddenly worsen.

Drug-induced hypersensitivity syndrome – Symptoms such as widespread redness of the skin, generalized rash, fever, general fatigue, and swelling of the lymph nodes (neck, armpits, groin, etc.) may occur.

Liver dysfunction – Symptoms such as fever, itching, rash, jaundice (yellowing of the skin and whites of the eyes), brown urine, general fatigue, and loss of appetite may occur.

Renal disorder – Symptoms such as fever, rash, decreased urine output, generalized swelling, general fatigue, joint pain (aching joints), and diarrhea may occur.

Interstitial pneumonia – Symptoms such as shortness of breath or difficulty breathing when climbing stairs or exerting oneself slightly, dry cough, and fever may occur. These symptoms may appear suddenly or persist.

Asthma – Symptoms such as wheezing or whistling sounds when breathing and difficulty breathing may occur.

3. The following symptoms may appear after taking this medicine. If these symptoms 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 warm water.
Age – Single Dose – Doses per Day
Adults (15 years of age or older) – 3 tablets – 3 times: take preferably within 30 minutes after meals.
11 to under 15 years of age – 2 tablets – 3 times: take preferably within 30 minutes after meals.
7 to under 11 years of age – 1 tablet – 3 times: take preferably within 30 minutes after meals.
Under 7 years of age – Do not take this medicine.

<Precautions Concerning Dosage and Administration>
(1) Strictly follow the dosage and administration.
(2) When giving this medicine to a child 7 years of age or older, have the child take it 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
– Provides sustained suppression of 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 expel phlegm, 1 of the causes of coughing.

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

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

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

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

Anhydrous caffeine – 60 mg
– Relieves headache.

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



●Precautions for Storage and Handling
(1) Store tightly sealed in a cool, dry place out of direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to another container. (This results in misuse or a change in 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, returning wet tablets to the bottle affects the other tablets, so do not return them.
(5) The filler in the bottle is for preventing tablet breakage during transport, so discard it after opening.
(6) Do not use this product after the indicated expiration date.
Also, use within 12 months after opening the bottle.
(7) Write the date the bottle was opened in the "Date Opened" field on the box.

[Other Information Stated 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 cause an excessive inflammatory reaction.
This inflammatory reaction causes respiratory symptoms such as sore throat, runny nose, cough and phlegm, as well as fever, etc.
First controlling and calming the inflammation is the key to relieving cold symptoms.



●Contact Information
Direct inquiries about this product to the store where you purchased it or to the contact below.
Daiichi Sankyo Healthcare Co., Ltd. Customer Service Office
3-14-10 Nihonbashi, Chuo-ku, Tokyo 103-8234
Phone 0120-337-336
Hours 9:00–17:00 (excluding Saturdays, Sundays, and public holidays)
For more information about Lulu

Manufacturer and Distributor
Daiichi Sankyo Healthcare Co., Ltd.
3-14-10 Nihonbashi, Chuo-ku, Tokyo
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