Colcol-S by Cho-A Pharm.Co.,Ltd. Colcol-S

Colcol-S by

Drug Labeling and Warnings

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

Drug Details [pdf]

COLCOL-S- acetaminophen, chlorpheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide hydrate, guaifenesin capsule 
Cho-A Pharm.Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Colcol-S

Active Ingredients

Acetaminophen 200.00mg

Chlorpheniramine Maleate 1.25mg

Pseudoephedrine Hydrochloride 15.00mg

Dextromethorphan Hydrobromide Hydrate 7.50mg

Guaifenesin 21.00mg

Purpose

Pain reliever/ fever reducer

Antihistamine

Bronchodilator/ Nasal decongestant

Cough 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 pains
• headache
• sore throat
• nasal congestion
• cough
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever

Warnings

Sore throat warning

If 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 use

with 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 have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dose

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts

These 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 warning

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.

Directions

Directions

Do not take more than directed (see overdose warning)

Adults and children 12 years and over

Take 2 capsules every 4 hours

Swallow whole; do not crush, chew or dissolve

Do not take more than 10 caplets in 24 hours

Children under 12 years

Ask 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

Colcol-S

COLCOL-S 
acetaminophen, chlorpheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide hydrate, guaifenesin capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58354-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	21 mg  in 320 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg  in 320 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 320 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 320 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1.25 mg  in 320 mg

Inactive Ingredients
Ingredient Name	Strength
CAFFEINE (UNII: 3G6A5W338E)	20 mg  in 320 mg

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	COL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58354-111-03	1 in 1 BOX	02/21/2019	12/25/2020
1	NDC: 58354-111-02	10 in 1 BLISTER PACK
1	NDC: 58354-111-01	320 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
unapproved drug other		02/21/2019	12/25/2020

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(58354-111)

Revised: 6/2024

Document Id: 1b8d0870-301f-5f05-e063-6394a90a27f6

34390-5

Set id: 82719258-a8a7-1885-e053-2991aa0a843c

Version: 7

Effective Time: 20240623