Colcol-S

Manufacturer
Cho-A Pharm.Co.,Ltd.
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:55:08

Label at a glance#

ProductColcol-S
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure8 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 200.00mg

Chlorpheniramine Maleate 1.25mg

Pseudoephedrine Hydrochloride 15.00mg

Dextromethorphan Hydrobromide Hydrate 7.50mg

Guaifenesin 21.00mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Antihistamine

Bronchodilator/ Nasal decongestant

Cough suppressant

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. (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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colcol-scolcol-s

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58354-11158354-111-01, 58354-111-02, 58354-111-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 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
1b8d0870-301f-5f05-e063-6394a90a27f682719258-a8a7-1885-e053-2991aa0a843c2024-06-23WarningsExact identifier
spl set id: 82719258-a8a7-1885-e053-2991aa0a843c

Reported adverse events (FAERS/openFDA)#

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