Pancold S Oral

Manufacturer
Dong Wha Pharm. Co., Ltd.
Effective date
2016-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:28:09

Label at a glance#

ProductPancold S Oral
Active ingredientAcetaminophen, Guaifenesin
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Purpose: Pain reliever/fever reducer, Cough suppressant

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Use

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Stop using and consult a doctor

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

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 cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeITF18806427035125GTIN-14: 18806427035125
GTIN storage (14 digits): 18806427035125
pancol s oral carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51352-010-012025-01-06C16284748780-19d75b9d1-0e67-f424-e053-dadaa90a57ce3d21e453-db6d-4c8a-b6f4-8ede319d0c95
51352-010-012020-01-31C16284748780-19d75b9d1-0e67-f424-e053-dadaa90a57ce3d21e453-db6d-4c8a-b6f4-8ede319d0c95

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
GUAIFENESINACTIVE MOIETY495W7451VQ1
CHLORPHENIRAMINE MALEATEINACTIVE INGREDIENTV1Q0O9OJ9Z1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51352-01051352-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b143991-7f70-3e0a-e063-6294a90abfe63d21e453-db6d-4c8a-b6f4-8ede319d0c952025-01-06WarningsExact identifier
spl set id: 3d21e453-db6d-4c8a-b6f4-8ede319d0c95

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.