COLCOL CO TAB.- triprolidine hydrochloride, pseudoephedrine hydrochloride tablet 
Cho-A Pharm.Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colcol Co Tab.

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.

colcol co tab image

COLCOL CO TAB. 
triprolidine hydrochloride, pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg  in 350 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 350 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58354-110-031 in 1 BOX02/01/2019
1NDC:58354-110-0210 in 1 BLISTER PACK
1NDC:58354-110-01350 mg in 1 CAPSULE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/201905/18/2023
Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
Establishment
NameAddressID/FEIBusiness Operations
Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-110)

Revised: 5/2023
 
Cho-A Pharm.Co.,Ltd.