HANSHINNOCOL- acetaminophen, cholorpheniramine maleate, dextromethorphan hydrobromide capsule
Han Kook Shin Yak Pharmaceutical Co., Ltd.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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HANSHINNOCOL CAPSULE
Keep out of reach of children
• In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Uses
• temporarily relieves these symptoms due to a cold or flu
• minor aches and pains
• headache
• nasal congestion
• runny nose
• cough
• sneezing
• sore throat
• excessive phlegm
• temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 3 doses in 24 hours, which is the maximum daily amount
• child takes more than 1 dose in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this productSore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• exceed recommended dosage and administration.
• with the following medication: Antitussive expectorants, other cold medication, antipyretic and analgesics, antihistamine drugs, sedatives, etc.
• for a long term
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product
• if you have previously experienced sensitivity to this medication (e.g., rash, skin redness, itching of skin, swollen throat, eyes, lips and other parts)
• if you had asthma after taking this medication or other antipyretic analgesics so far
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user have
• liver disease
• thyroid disease
• diabetes
• hypertension
• weak constitution or high fever
• heart disease or the elderly
• kidney disease
• glaucoma (e.g., eye pain or dimmed vision, etc.)
• parents or siblings who are susceptible to urticaria, contact dermatitis, bronchial asthma, allergic rhinitis, migraines, food allergies, etc.
• previously experienced drug allergies (e.g., fever, rash, joint pain, asthma, skin irritation, etc.)
• varicella or influenza or infants and children under 14 years of age who are suspected of varicella or influenza
• difficulty in urination
• edema
• undergoing therapy or dental treatment
Ask a doctor or pharmacist before use (for children and infants)
• Children should take this medication under the guidance of their parents.
• Infants under 2 years old should be given treatment by a doctor and should not take this medication unless it is absolutely necessary; infants under 2 years old should take this medication with the guardian's awareness and should be monitored closely.
Ask a doctor or pharmacist before use if the user is taking the blood
thinning drug warfarin
When using this product
• may cause drowsiness
• avoid alcoholic drinks
• avoid driving or operating machinery
• may cause slight irritation to skin, eyes, and mucous membranes
• together with preparations containing potassium, licorice components, glycyrrhizic acid (or its salt), or loop diuretics (e.g., furosemide and ethacrynic acid), or thiazide diuretics (e.g, trichlormethiazide), muscle disorders caused by pseudoaldosteronism and hypokalemia may readily occur. Please use it with caution.
• please use it with caution, this product contains dye Yellow No. 5 (Sunset Yellow FCF). Individuals who are sensitive or have a history of allergy to this ingredient .
Stop use and ask a doctor if
• occurrence of reduced urine output, swelling of the face or limbs, heavy eyelids, stiffness of hands, high blood pressure or headache, and other symptoms after taking this product.
• Pseudo aldosterone disease: When individuals are in long-term use of the preparation of which the daily dose of licorice is over 1g, symptoms of pseudoaldosteronism, such as hypokalemia, increased blood pressure, sodium and water retention, edema, and weight gain, may occur. After a full observaion (e.g., determination of serum potassium concentration),
• Myopathy (muscle disorders): Hypokalemia may lead to muscle diseases.
• fatigue, spastic quadriplegia, or paralysis are confirmed through a full observation.
• rash, skin redness, nausea, vomiting, loss of appetite, difficulty in urination, vertigo, etc., occur
• urticaria, swollen throat, eyelids, lips, and other parts, chest congestion accompanied by paleness, cold limbs, cold sweats, shortness of breath, etc.
• scald-like blisters, etc., occurring on systemic skin, mouth and eye mucous membrane accompanied by high fever.
• asthma
• there is no remission of symptoms after several dosages
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage.
Directions
• do not take more than the recommended dose
• adults: take 2 capsules per session, 3 times per day, 30 minutes after meal.
• children 7 to 14 years: take 1 capsule per session, 3 times per day, 30 minutes after meal. (under the guidance of parents.)
• children 2 to 7 years: ask a doctor under the guidance of parents
• under 1 year : do not use
| HANSHINNOCOL
acetaminophen, cholorpheniramine maleate, dextromethorphan hydrobromide capsule |
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| Labeler - Han Kook Shin Yak Pharmaceutical Co., Ltd. (689277536) |
| Registrant - Han Kook Shin Yak Pharmaceutical Co., Ltd. (689277536) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Han Kook Shin Yak Pharmaceutical Co., Ltd. | 689277536 | manufacture(53153-102) | |
Revised: 6/2021
Document Id: c5eee728-a75d-2534-e053-2995a90a1fb3
Set id: d3917401-7ad6-406a-90fd-e4acd1425074
Version: 7
Effective Time: 20210629
Han Kook Shin Yak Pharmaceutical Co., Ltd.