NDC 58354-111 Colcol-s

Acetaminophen, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Hydrate, Guaifenesin

NDC Product Code 58354-111

NDC Code: 58354-111

Proprietary Name: Colcol-s 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: Acetaminophen, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Hydrate, Guaifenesin 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):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
COL
Score: 1

Code Structure
  • 58354 - Cho-a Pharm.co.,ltd.
    • 58354-111 - Colcol-s

NDC 58354-111-03

Package Description: 1 BLISTER PACK in 1 BOX > 10 CAPSULE in 1 BLISTER PACK (58354-111-02) > 320 mg in 1 CAPSULE (58354-111-01)

NDC Product Information

Colcol-s with NDC 58354-111 is a a human over the counter drug product labeled by Cho-a Pharm.co.,ltd.. The generic name of Colcol-s is acetaminophen, chlorpheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide hydrate, guaifenesin. The product's dosage form is capsule and is administered via oral form.

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

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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-s 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.

  • GUAIFENESIN 21 mg/320mg
  • ACETAMINOPHEN 200 mg/320mg
  • DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/320mg
  • PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/320mg
  • CHLORPHENIRAMINE MALEATE 1.25 mg/320mg

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.

  • CAFFEINE (UNII: 3G6A5W338E)

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: 02-21-2019 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-s Product Label Images

Colcol-s 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

Acetaminophen 200.00mgChlorpheniramine Maleate 1.25mgPseudoephedrine Hydrochloride 15.00mgDextromethorphan Hydrobromide Hydrate 7.50mgGuaifenesin 21.00mg

Purpose

Pain reliever/ fever reducerAntihistamineBronchodilator/ Nasal decongestantCough suppressant

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

  • For the temporary relief of the following cold/flu symptoms:minor aches and painsheadachesore throatnasal congestioncoughhelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productivetemporarily reduces fever

Warnings

  • Sore throat warningIf sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • If you have ever had an allergic reaction to this product or any of its ingredients.
  • Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysemacough that occurs with too much phlegm (mucus)Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarinWhen using this product do not exceed recommended doseStop use and ask a doctor ifnervousness, dizziness, or sleeplessness occurpain, nasal congestion or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lastsThese could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children.Overdose warningIn case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DirectionsDo not take more than directed (see overdose warning)Adults and children 12 years and overTake 2 capsules every 4 hoursSwallow whole; do not crush, chew or dissolveDo not take more than 10 caplets in 24 hoursChildren under 12 yearsAsk a doctor

Inactive Ingredients

Caffeine, Coated Ascorbic Acid, Ginseng Dried Extract, Thiamine Nitrate, Riboflabvin, Coated Ascorbic Acid, Povidone K30, Magnesium Stearate, Magnesium silicate, Ethanol, Sky blue hard capsule

* Please review the disclaimer below.

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