PANCOLD S ORAL- acetaminophen, guaifenesin liquid

Pancold S Oral by

Drug Labeling and Warnings

Pancold S Oral by is a Otc medication manufactured, distributed, or labeled by Dong Wha Pharm. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PANCOLD S ORAL 
acetaminophen, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51352-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	9000 mg  in 30
Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	Guaifenesin	2499 mg  in 30

Inactive Ingredients
Ingredient Name	Strength
METHYLEPHEDRINE HYDROCHLORIDE (UNII: 8ONA78V6FO)
Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51352-010-01	30 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2014

Labeler - Dong Wha Pharm. Co., Ltd. (687745240)

Registrant - Dong Wha Pharm. Co., Ltd. (687745240)

Establishment
Name	Address	ID/FEI	Business Operations
Dong Wha Pharm. Co., Ltd.		687745240	manufacture(51352-010)