Colcol Co Tab.

Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride


Cho-a Pharm.co.,ltd.
Human Otc Drug
NDC 58354-110
Colcol Co Tab. also known as Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride is a human otc drug labeled by 'Cho-a Pharm.co.,ltd.'. National Drug Code (NDC) number for Colcol Co Tab. is 58354-110. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Colcol Co Tab. drug includes Pseudoephedrine Hydrochloride - 60 mg/350mg Triprolidine Hydrochloride - 2.5 mg/350mg . The currest status of Colcol Co Tab. drug is Active.

Drug Information:

Drug NDC: 58354-110
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Colcol Co Tab.
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Cho-a Pharm.co.,ltd.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:PSEUDOEPHEDRINE HYDROCHLORIDE - 60 mg/350mg
TRIPROLIDINE HYDROCHLORIDE - 2.5 mg/350mg
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Feb, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part341
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Cho-A Pharm.Co.,Ltd.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1099446
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:8806446013015
UPC stands for Universal Product Code.
UNII:6V9V2RYJ8N
YAN7R5L890
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Adrenergic alpha-Agonists [MoA]
alpha-Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
58354-110-031 BLISTER PACK in 1 BOX (58354-110-03) / 10 CAPSULE in 1 BLISTER PACK (58354-110-02) / 350 mg in 1 CAPSULE (58354-110-01)01 Feb, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose pain reliever cough suppressant expectorant nasal decongestant

Product Elements:

Colcol co tab. triprolidine hydrochloride, pseudoephedrine hydrochloride pseudoephedrine hydrochloride pseudoephedrine magnesium stearate lactose monohydrate anhydrous lactose triprolidine hydrochloride triprolidine

Indications and Usage:

Uses • temporarily relieves these symptoms due to a cold or flu • minor aches and pains • headache • nasal congestion • cough • sore throat • dried throat

Warnings:

Warnings oral use only use only recommended dosage and administration do not use if the user • is under 5 years old • has galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption, or hereditary illness/ disease. ask a doctor, pharmacist, or dentist before use if the user have (is) • high blood pressure (hypertension) • heart disease • kidney disease • edema • weak constitution • stomach disorder • previously experienced drug allergies (e.g., rash, skin redness, skin irritation, etc.) • doctor’s treatment, undergoing therapy, or taken other medication • aged person • please use it with caution, this product contains dye yellow no. 5 (sunset yellow fcf). individuals who are sensitive or have a history of allergy to this ingredient. when using this product • use only recommended dosage and administration • not recommended long-term use, but if you take this product with long-term ask doctor,
pharmacist, or dentist. • children should take this medication under the guidance of their parents • together with preparations containing potassium, licorice components, glycyrrhizic acid (or its salt), or loop diuretics (e.g., furosemide and ethacrynic acid), or thiazide diuretics (e.g, trichlormethiazide), muscle disorders caused by pseudoaldosteronism and hypokalemia may readily occur. please use it with caution. • together with any other herbal medicine, please use it with caution and avoid the overlapping ingredients. stop use and ask a doctor, pharmacist, or dentist if • occurrence of reduced urine output, swelling of the face or limbs, heavy eyelids, stiffness of hands, high blood pressure or headache, and other symptoms after taking this product. • pseudo aldosterone disease: when individuals are in long-term use of the preparation of which the daily dose of licorice is over 1g, symptoms of pseudoaldosteronism, such as hypokalemia, increased blood pressure, sodium and water retention, edema, and weight gain, may occur. after a full observaion (e.g., determination of serum potassium concentration), • myopathy (muscle disorders): hypokalemia may lead to muscle diseases. • fatigue, spastic quadriplegia, or paralysis are confirmed through a full observation. • rash, skin redness, nausea, vomiting, loss of appetite, difficulty in urination, vertigo, etc., occur • urticaria, swollen throat, eyelids, lips, and other parts, chest congestion accompanied by paleness, cold limbs, cold sweats, shortness of breath, etc. • there is no remission of symptoms after several dosages if pregnant or breast-feeding, ask doctor, or health professional before use. store at cool temperature and dry place with a closed container. avoid direct sunlight. - store in a container other than its original container is equivalent to misuse. in order to prevent the reduction of drug efficacy, keep the product in its original container for storage.

Dosage and Administration:

Directions • do not exceed recommended dose • adults: take 1 tablet per session, 3 times per day, before meal or between meals. • children 12 to 14 years: take 1/2 capsule per session, 3 times per day, before meal or between meals.

Package Label Principal Display Panel:

Colcol co tab. colcol co tab image


Comments/ Reviews:

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