PANCOLD S ORAL (ACETAMINOPHEN, GUAIFENESIN) LIQUID [DONG WHA PHARM. CO., LTD.]

PANCOLD S ORAL (ACETAMINOPHEN, GUAIFENESIN) LIQUID [DONG WHA PHARM. CO., LTD.]
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NDC 51352-010-01
Set ID 3d21e453-db6d-4c8a-b6f4-8ede319d0c95
Category HUMAN OTC DRUG LABEL
Packager Dong Wha Pharm. Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART341
  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PANCOLD S ORAL 
    acetaminophen, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51352-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen9000 mg  in 30 
    Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) Guaifenesin2499 mg  in 30 
    Inactive Ingredients
    Ingredient NameStrength
    METHYLEPHEDRINE HYDROCHLORIDE (UNII: 8ONA78V6FO)  
    Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51352-010-0130 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2014
    Labeler - Dong Wha Pharm. Co., Ltd. (687745240)
    Registrant - Dong Wha Pharm. Co., Ltd. (687745240)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong Wha Pharm. Co., Ltd.687745240manufacture(51352-010)

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