NDC 58354-110 Colcol Co Tab.

Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride

NDC Product Code 58354-110

NDC Code: 58354-110

Proprietary Name: Colcol Co Tab. Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
7 MM
Score: 2

Code Structure
  • 58354 - Cho-a Pharm.co.,ltd.
    • 58354-110 - Colcol Co Tab.

NDC 58354-110-03

Package Description: 1 BLISTER PACK in 1 BOX > 10 CAPSULE in 1 BLISTER PACK (58354-110-02) > 350 mg in 1 CAPSULE (58354-110-01)

NDC Product Information

Colcol Co Tab. with NDC 58354-110 is a a human over the counter drug product labeled by Cho-a Pharm.co.,ltd.. The generic name of Colcol Co Tab. is triprolidine hydrochloride, pseudoephedrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cho-a Pharm.co.,ltd.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Colcol Co Tab. Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/350mg
  • TRIPROLIDINE HYDROCHLORIDE 2.5 mg/350mg

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cho-a Pharm.co.,ltd.
Labeler Code: 58354
FDA Application Number: part341 Additional informationCallout TooltipWhat is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Colcol Co Tab. Product Label Images

Colcol Co Tab. 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 Ingredients

Triprolidine Hydrochloride 2.5mgPseudoephedrine Hydrochloride 60mg

Purpose

Pain relievercough suppressantexpectorantnasal decongestant

Keep Out Of Reach Of Children

• In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

• temporarily relieves these symptoms due to a cold or flu

• minor aches and pains

• headache

• nasal congestion

• cough

• sore throat

• dried throat

Warnings

Oral use onlyUse only recommended dosage and administrationDo 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.

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.

Inactive Ingredients

Lactose HydrateCorn StarchHydroxypropylcelluloseMagnesium StearateEthanol

* Please review the disclaimer below.

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