NDC 51352-010 Pancold S Oral

NDC Product Code 51352-010

NDC CODE: 51352-010

Proprietary Name: Pancold S Oral What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

  • 51352 - Dong Wha Pharm. Co., Ltd.

NDC 51352-010-01

Package Description: 30 LIQUID in 1 CARTON

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Pancold S Oral with NDC 51352-010 is a product labeled by Dong Wha Pharm. Co., Ltd.. The product's dosage form is and is administered via form.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • METHYLEPHEDRINE HYDROCHLORIDE (UNII: 8ONA78V6FO)
  • CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dong Wha Pharm. Co., Ltd.
Labeler Code: 51352
Start Marketing Date: 11-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Pancold S Oral Product Label Images

Pancold S Oral Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

* Please review the disclaimer below.