Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 569cfe1e-a9ed-4c85-94e7-1f42d5b1897a
Route
ORAL
Published
Effective Date 2014-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (1.25 mg)
Inactive Ingredients
Povidone Magnesium Stearate Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 3;hp;x Shape: capsule Color: yellow Size: 20 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-27

Description

chlorpheniramine maleate, acetaminophen, pseudoephedrine hydrochloride, cloperastin hydrochloride, lysozyme hydrochloride, guaifenesin, thiamine nitrate, riboflavin, platycodon 50% ethanol dried extract, cinnamon dried extract, glycyrrhize dried extract


Medication Information

Warnings and Precautions

[DO NOT USE]

if you are hypersensitive to this drug and any component of this drug

if you have a history of asthma after taking this drug, other cold drugs or antipyreticanalgesics

in infants under 3 months of age

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug

with antitussive expectorants, other cold medicines, antipyretic-analgesics, sedatives,

antihistamines(certain drugs for rhinitis, preventive drugs for travel sickness, allergies)



[ASK A DOCTOR OR PHARMACIST BEFORE USE]

in infants or children under 15 years infected with chickenpox or influenza

in infants under 2 years of age only when it is necessary. Inform to the guardian/s and

monitor closely while administering

if you are genetically prone to uticaria, contact dermatitis, bronchial asthma, allergic rhinitis,

migraine, food allergy

If you have allergic reactions (e.g., fever, rash, arthralgia, asthma, itch, etc.) to this drug and

any component of this drug

if you have liver disease, kidney disease, heart disease, thyroid disease, diabetes, high blood

pressure, edema, stomach-duodenal ulcer, glaucoma, dysuria, high fever

if you are elderly or week

if you have bleeding , ache and discomfort in stomach

If (possibly) pregnant or breast-feeding

If you are taking a prescription drug for diabetes, goat, arthritis, anticoagulants and steroids

if you have cough by smoking, asthma, chronic bronchitis, emphysema, cough accompanied

with excessive sputum, fever, rash, persistent headache and cough lasting more than 1 week,

recurrent cough or chronic cough



[STOP USE AND ASK A DOCTOR IF]

you experience any of the following symptoms:

rash, redness, itching, nausea, vomiting, loss of appetite, constipation, edema, dysuria, severe

or persistent thirst, dizziness, anxiety, shivering, insomnia

you experience any of the following severe symptoms:

anaphylaxis (e.g., immediate rash, edema, shortness of breath along with paling of face,

cold sweat, cold hands and feet)

Stevens-Johnson syndrome (mucocutaneous syndrome) or Lyell syndrome (toxic epidermal

necrosis) (e.g., rash and redness accompanied with high fever, blisters as in burn over the

body or mucous membranes of mouth or eyes) asthma

liver dysfunction (e.g., drowsiness, jaundice)

interstitial pneumonia (e.g., shortness of breath, fever accompanied with cough)

aldosteronism: long-term continuous use of preparations containing over than 1g as licorice

(daily maximum dose) may cause hypokalemia, increased blood pressure, fluid retention of

sodium, edema, weight gain, aldosteronism. Observe closely (blood potassium concentration)

and stop taking this drug and when you have above symptoms.

myopathy may rarely occur as a result of hypokalemia. Observe closely and stop taking this

drug when you appear symptoms such as weakness, limb spasms, and numbness.



[WHEN USING THIS PRODUCT]

do not exceed recommended dosage

do not take for a long period of time

administer to children under the guidance and supervision of a guardian

avoid alcoholic drinks

do not drive a motor vehicle or operate machinery

barbiturates, tricyclic antidepressants, and alcohol may reduce the ability to metabolize large

quantities of acetaminophen, thereby increasing the plasma half-life of acetaminophen

myopathy may occur due to aldosteronism or hypokalemia when administered with drugs

containing potassium, licorice, glycyrrhizin acid or its salts, loop diuretics (furosemide,

ethacrynic acid) or thiazide diuretic (trichlormethiazide).

Indications and Usage

Adults and children 15 years or over: take 2 capsules after meal 3 times a day

Children between 8 and 14 years: take 1 capsule after meal 3 times a day



Dosage and Administration

for oral administration



Description

chlorpheniramine maleate, acetaminophen, pseudoephedrine hydrochloride, cloperastin hydrochloride, lysozyme hydrochloride, guaifenesin, thiamine nitrate, riboflavin, platycodon 50% ethanol dried extract, cinnamon dried extract, glycyrrhize dried extract

Section 50565-1

keep out of reach of the children



Section 51727-6

povidone, light anhydrous silicic acid, magnesium stearate



Section 51945-4
Section 55105-1

- temporarily relieves these cold symptomes

runny nose, nasal congestion, sneezing, sore throat, cough, sputum, headache, minor aches and pain

- temporarily reduces fever



Section 55106-9

chlorpheniramine maleate, acetaminophen, pseudoephedrine hydrochloride, cloperastin hydrochloride, lysozyme hydrochloride, guaifenesin, thiamine nitrate, riboflavin, platycodon 50% ethanol dried extract, cinnamon dried extract, glycyrrhize dried extract




Structured Label Content

Indications and Usage (34067-9)

Adults and children 15 years or over: take 2 capsules after meal 3 times a day

Children between 8 and 14 years: take 1 capsule after meal 3 times a day



Dosage and Administration (34068-7)

for oral administration



Warnings and Precautions (34071-1)

[DO NOT USE]

if you are hypersensitive to this drug and any component of this drug

if you have a history of asthma after taking this drug, other cold drugs or antipyreticanalgesics

in infants under 3 months of age

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug

with antitussive expectorants, other cold medicines, antipyretic-analgesics, sedatives,

antihistamines(certain drugs for rhinitis, preventive drugs for travel sickness, allergies)



[ASK A DOCTOR OR PHARMACIST BEFORE USE]

in infants or children under 15 years infected with chickenpox or influenza

in infants under 2 years of age only when it is necessary. Inform to the guardian/s and

monitor closely while administering

if you are genetically prone to uticaria, contact dermatitis, bronchial asthma, allergic rhinitis,

migraine, food allergy

If you have allergic reactions (e.g., fever, rash, arthralgia, asthma, itch, etc.) to this drug and

any component of this drug

if you have liver disease, kidney disease, heart disease, thyroid disease, diabetes, high blood

pressure, edema, stomach-duodenal ulcer, glaucoma, dysuria, high fever

if you are elderly or week

if you have bleeding , ache and discomfort in stomach

If (possibly) pregnant or breast-feeding

If you are taking a prescription drug for diabetes, goat, arthritis, anticoagulants and steroids

if you have cough by smoking, asthma, chronic bronchitis, emphysema, cough accompanied

with excessive sputum, fever, rash, persistent headache and cough lasting more than 1 week,

recurrent cough or chronic cough



[STOP USE AND ASK A DOCTOR IF]

you experience any of the following symptoms:

rash, redness, itching, nausea, vomiting, loss of appetite, constipation, edema, dysuria, severe

or persistent thirst, dizziness, anxiety, shivering, insomnia

you experience any of the following severe symptoms:

anaphylaxis (e.g., immediate rash, edema, shortness of breath along with paling of face,

cold sweat, cold hands and feet)

Stevens-Johnson syndrome (mucocutaneous syndrome) or Lyell syndrome (toxic epidermal

necrosis) (e.g., rash and redness accompanied with high fever, blisters as in burn over the

body or mucous membranes of mouth or eyes) asthma

liver dysfunction (e.g., drowsiness, jaundice)

interstitial pneumonia (e.g., shortness of breath, fever accompanied with cough)

aldosteronism: long-term continuous use of preparations containing over than 1g as licorice

(daily maximum dose) may cause hypokalemia, increased blood pressure, fluid retention of

sodium, edema, weight gain, aldosteronism. Observe closely (blood potassium concentration)

and stop taking this drug and when you have above symptoms.

myopathy may rarely occur as a result of hypokalemia. Observe closely and stop taking this

drug when you appear symptoms such as weakness, limb spasms, and numbness.



[WHEN USING THIS PRODUCT]

do not exceed recommended dosage

do not take for a long period of time

administer to children under the guidance and supervision of a guardian

avoid alcoholic drinks

do not drive a motor vehicle or operate machinery

barbiturates, tricyclic antidepressants, and alcohol may reduce the ability to metabolize large

quantities of acetaminophen, thereby increasing the plasma half-life of acetaminophen

myopathy may occur due to aldosteronism or hypokalemia when administered with drugs

containing potassium, licorice, glycyrrhizin acid or its salts, loop diuretics (furosemide,

ethacrynic acid) or thiazide diuretic (trichlormethiazide).

Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

povidone, light anhydrous silicic acid, magnesium stearate



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

- temporarily relieves these cold symptomes

runny nose, nasal congestion, sneezing, sore throat, cough, sputum, headache, minor aches and pain

- temporarily reduces fever



Section 55106-9 (55106-9)

chlorpheniramine maleate, acetaminophen, pseudoephedrine hydrochloride, cloperastin hydrochloride, lysozyme hydrochloride, guaifenesin, thiamine nitrate, riboflavin, platycodon 50% ethanol dried extract, cinnamon dried extract, glycyrrhize dried extract




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