FDA Label for Pancold S Oral

View Indications, Usage & Precautions

Pancold S Oral Product Label

The following document was submitted to the FDA by the labeler of this product Dong Wha Pharm. Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active Ingredients 1 bottle contains: Acetaminophen 300mg, Guaifenesin 83.3mg


Inactive Ingredient



Inactive Ingredients: Caffeine anhydrous, dl-Methylephedrine HCl, Chlorpheniramine maleate


Purpose



Purpose: Pain reliever/fever reducer, Cough suppressant


Warnings



Warnings: A person who takes more than 3 cups of alcohol everyday should consult physician or pharmacist before using this medicine or another antipyretic analgesics. If the person takes this medicine, liver damage may be induced.


Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN


Use



Use: Relief of the symptomatic common cold (runny nose, stuffy nose, sneezing, cough, sore throat, sputum, chill, fever, headache, joint pain, myalgia)


Directions



Directions: Adult, 30mL, 3 times daily, 30 minutes after meals


Stop Using And Consult A Doctor



Stop using and consult a doctor: Immediately discontinue taking this medicine in case of followings caused by this medicine, and consult your physician, dentist and pharmacist with this paper. 1) rash, erythema, pruritus, vomiting, anorexia, constipation, edema, dysuria, thirst (continuously or severely), dizziness, anxiety, tremor, insomnia 2) shock(anaphylaxis): hives, edema, heavy feeling chest symptoms with looking pale, cold hands, cold sweats, dyspnea 3) Stevens Johnson syndrome, Lyell syndrome 4) asthma 5) liver disorder : languor and jaundice can be occurred. 6) Interstitial lung disease : It is accompanied by cough and dyspnea and/or fever can be occurred. In case that the symptoms are not improved though taking this medicine more than 5-6 times.


Ask A Doctor



Ask a doctor: Following patients should consult a physician, dentist or pharmacist before using. 1) Infants and children under 15 years old infected with chicken pox or influenza or suspected of infection (If there are changes in behavior accompanied by vomiting, because it can be the initial symptom of Reye's Syndrome rarely, please consult your physician.) 2) Please avoid administrating to infants under 3 months and even if patients are more than 3 months, all children under 2 years old should receive the appropriate medication related this medication. Unless absolutely necessary, don't administrate it to them. And if necessary to administrate it, notify it to their parents and monitor them carefully. 3) Patients with constitution causing easily hives, contact dermatitis, asthma, allergic rhinitis, migraine and food allergy 4) Patients who has medical history of allergic reaction (fever, rash, arthralgia, asthma, pruitus) 5) Patients who have diseases such as hepatic, cardiovascular, renal or thyroid disorder, diabetes, hypertension, duodenal ulcer, glaucoma(eye pain, blurred vision), dysuria, and the aged, fragile person, person with high fever. 6) Patients with or recurrence of heart burn, stomach displeasure, gastric pain or having the problem of ulcer and hemorrhages. 7) Pregnant women or women of childbearing potential, nursing mothers. 8) Patients with medication of physician or dentist (Taking medicines for diabetes, gout, arthritis, anticoagulants, steroid medicines and others.) 9) Patients with following cough - cough accompanied by smoking, chronic bronchitis, emphysema, immoderate sputum, cough continued more than 1 week and/or recurred, chronic cough, cough accompanied by fever, rash and continuous headache.


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