COLCOL CO TAB.- triprolidine hydrochloride, pseudoephedrine hydrochloride tablet

Colcol Co Tab. by

Drug Labeling and Warnings

Colcol Co Tab. by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Triprolidine Hydrochloride 2.5mg

Pseudoephedrine Hydrochloride 60mg

Purpose

Pain reliever

cough suppressant

expectorant

nasal 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 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

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 Hydrate

Corn Starch

Hydroxypropylcellulose

Magnesium Stearate

Ethanol

Colcol Co Tab.

INGREDIENTS AND APPEARANCE

COLCOL CO TAB. 
triprolidine hydrochloride, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58354-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg  in 350 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 350 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58354-110-03	1 in 1 BOX	02/01/2019
1	NDC: 58354-110-02	10 in 1 BLISTER PACK
1	NDC: 58354-110-01	350 mg in 1 CAPSULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2019

Labeler - Cho-A Pharm.Co.,Ltd. (688056831)

Registrant - Cho-A Pharm.Co.,Ltd. (688056831)

Establishment
Name	Address	ID/FEI	Business Operations
Cho-A Pharm.Co.,Ltd.		688056831	manufacture(58354-110)