Panto Flu

SAMSUNG PHARM IND. CO., LTD.
SAMSUNG PHARM IND. CO., LTD.

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT
• INACTIVE INGREDIENT
• PURPOSE
• WARNINGS
• KEEP OUT OF REACH OF CHILDREN
• INDICATIONS AND USAGE
• DOSAGE AND ADMINISTRATION
• PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

Active ingredients: Dextromethorphan Hydrobromide Hydrate 15mg, Chlorpheniramine Maleate 2.5mg

INACTIVE INGREDIENT

Inactive ingredients:
Ascorbic Acid, Acetaminophen, DL-Methylephedrine Hydrochloride, Lactose Hydrate, Glucose, Aspartame, D-Mannitol, Citric Acid Hydrate, Carboxymethylcellulose Calcium, β-Cyclodextrin, Orange Flaver cotton, Lemon Flavor cotton, Yellow No. 4(Tartrazine)

PURPOSE

Effective for: relieving cold symptoms (runny nose, stuffed nose, sneezing, throat pain, coughing, phlegm, chills, fever, headache, arthralgia, muscle pain)

WARNINGS

1. Warnings
1) Patients who consume more than three glasses of alcohol on a regular basis must consult a doctor or pharmacist before taking this drug or other antipyretic-analgesics.
Patients like this may suffer from liver damage if this drug is taken.
2) The artificial sweetening agent “Aspartame” in this drug is broken down within the body and metabolized into phenylalanine.
Must not be taken by phenylketonuric patients that need to control phenylalanine intake.

2. The following patients must administer with care
This drug consists of food yellow no. 4 (tartrazine) therefore patients who are sensitive to this component or allergic to it must administer with care.

3. The following patients must consult a doctor or pharmacist before administering this drug.
1) Patient who has parents or siblings suffering from rashes, contact dermatitis, bronchial asthma, allergic coryza, migraines and food allergies.
2) Patients who have had allergic reactions (e.g. fevers, rashes, arthralgia, asthma, pruritus and etc.) from this drug.
3) Children below 14 years who are infected with or are suspected of chickenpox or influenza
4) Patients with liver, kidney or thyroid disease, diabetes, high blood pressure. Patients that are weak and have a high fever.
5) Patients with cardiac disease or of old age
6) Patients with glaucoma (Eg: pain in the eyes, gloomy eyes), patients with dysuria
7) Pregnant women, women who have potential to become pregnant and lactating women
8) Patients being cured by doctors or dentists

4. Other precautions when administering this drug
1) Follow the given instructions and dosages
2) Do not administer simultaneously with other drugs
Antitussive expectorants, other cold drugs, antipyretics & analgesics, antihistaminics and sedatives
3) When administering to children, it must be administered under the supervision of a parent or guardian
4) Avoid administration to infants less than 3 months old. Prevent administration to infants between 3 months and 1 year unless inevitable.

5. Be cautious of the following issues when administering or after administering this drug
1) If patients experience symptoms of rashes, flares, nausea, vomitting, constipation, lack of appetite, dysuria and dizziness, stop taking the drug and consult a doctor or pharmacist.
(Contains anti-histaminics for dysuria)
2) Drowsiness may occur during administration, therefore avoid administering while driving or operating machines (Contains anti-histaminics)
3) If administered numerous times and there is no change in symptoms, stop administering the drug and consult a doctor or pharmacist.
4) Do not administer continuously on a long term basis

6. Storage directions
1) Store in places out of the reach of children
2) Keep away from direct sunlight and in cool places with low humidity.
3) Do not store in different containers in order to prevent misuse and preserve quality

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

Dosage:
Adult (over 15 years old) 1 chartula at a time
Children over 11 years - below 15 years 2 chartula at a time
over 7 years - below 11 years 1/2 chartula at a time
Take 3 times daily, 30 minutes after eating
Stir one chartual in one cup (approximately 150mL) of hot or ordinary water

Permisssible amount per day:
Must adjust aspartame content to below 40mg/kg/1 per day, the recommended amount by the WHO
60kg Adult : Maximum dosage per day, 2.4g

DOSAGE AND ADMINISTRATION

Dosage:
Adult (over 15 years old) 1 chartula at a time
Children over 11 years - below 15 years 2 chartula at a time
over 7 years - below 11 years 1/2 chartula at a time
Take 3 times daily, 30 minutes after eating
Stir one chartual in one cup (approximately 150mL) of hot or ordinary water

Permisssible amount per day:
Must adjust aspartame content to below 40mg/kg/1 per day, the recommended amount by the WHO
60kg Adult : Maximum dosage per day, 2.4g

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL