triprolidine hydrochloride, pseudoephedrine hydrochloride

Manufacturer
Cho-A Pharm.Co.,Ltd.
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:55:08

Label at a glance#

ProductColcol Co Tab.
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Triprolidine Hydrochloride 2.5mg

Pseudoephedrine Hydrochloride 60mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

cough suppressant

expectorant

nasal decongestant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• 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

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to a cold or flu

• minor aches and pains

• headache

• nasal congestion

• cough

• sore throat

• dried throat

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

Lactose Hydrate

Corn Starch

Hydroxypropylcellulose

Magnesium Stearate

Ethanol

Colcol Co Tab.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colcol co tab imagecolcol co tab image

Products#

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DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58354-11058354-110-01, 58354-110-02, 58354-110-03

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
1b8cf3bb-81e9-adce-e063-6294a90a763a80dec6c1-12fb-94f0-e053-2991aa0ae10a2024-06-23WarningsExact identifier
spl set id: 80dec6c1-12fb-94f0-e053-2991aa0ae10a

Reported adverse events (FAERS/openFDA)#

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