ColdaeWon Nose A

Manufacturer
Daewon Pharmaceutical Co., Ltd. | Daewon Pharm. Co., Ltd. Hwaseong Factory
Effective date
2019-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:07:34

Label at a glance#

ProductColdaeWon Nose A
Active ingredientAcetaminophen, PHENYLEPHRINE HYDROCHLORIDE, Chlorpheniramine Maleate
Label structure10 sections

Indications and uses

Uses temporarily relieves common cold/flu symptoms: • runny nose • sneezing • nasal congestion • sore throat • fever • headache • minor pains and aches

Dosage and administration

Directions: • take only as directed • do not exceed 8 doses per 24 hours One dose 30 minutes after meals, three times a day adults & children 12 yrs & over ---------- 20 mL/dose children under 12 yrs ---------- do not use

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL pouch)

Acetaminophen 300 mg
Chlorpheniramine Maleate 2.5 mg
Phenylephrine HCl 10 mg

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

xanthan gum, stevion 100s, acesulfame potassium, concentrated glycerin, sucralose, d-sorbitol solution, xylitol, sodium chloride, povidone k30, propylene glycol, ethanol, disodium edetate hydrate, citric acid, sodium citrate hydrate, sodium benzoate, lemon essence, apple mint flavor 514165, red no. 40, purified water

PURPOSE

OTC - PURPOSE SECTION

Purpose:
- Pain reliever/fever reducer
- Antihistamine/immunosuppressant
- Nasal decongestant

WARNINGS

WARNINGS SECTION

Warnings:

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 8 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert: If you have ever experienced allergic reactions induced by drugs. Symptoms may include: • Skin reddening • Blisters • Rash
If a skin reaction occurs, stop use and seek medical help right away.

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.

Reye’s syndrome: a chickenpox or influenza-suspected infant or child under 15 years of age
If it is accompanied by nausea or vomit, it may be early symptoms of Reye’s syndrome, rare but serious, 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 conditions an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
• liver disease • heart disease • renal disease • high blood pressure • thyroid disease
• diabetes • glaucoma • dysuria • weak condition • high fever
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, pulmonary emphysema, and excessive sputum production
• trouble urinating due to enlarged prostate gland
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizer
• taking blood thinning drug warfarin

When using this product
• observe usage and dosage instructions.
• do not take this drug for a long term.
• children should take this drug under the guardians’ supervision.
• do not drink alcohol while you are taking this drug.
• tends to cause drowsiness, avoid driving cars and operating machinery while taking this drug.
• patients, administered with barbital drugs, tricyclic antidepressants, or alcohol, tend to lack the ability to metabolize lots of acetaminophen, their plasma elimination half-life may increase.

Stop use and ask a doctor if
• cough and pain gets worse or persist for more than a week and accompanied by rash, flare, itching, nausea, vomiting, edema (swelling), dysuria, or insomnia.
• fever gets worse or lasts more than 3 days.
• new symptoms occur.
• cough come back or occurs with rash or headache that lasts.
These could be signs of a serious condition.

If pregnant, potentially-pregnant, or breast-feeding, ask a health professional before use.

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

Uses temporarily relieves common cold/flu symptoms:
• runny nose • sneezing • nasal congestion • sore throat • fever • headache • minor pains and aches

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

• take only as directed • do not exceed 8 doses per 24 hours
One dose 30 minutes after meals, three times a day
adults & children 12 yrs & over ---------- 20 mL/dose
children under 12 yrs ---------- do not use

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information
• each 20 ml contains: sodium 27 mg
• store between 20~25℃ (68~77℉).
• protect from direct sunlight and keep in a low-humidity and cool place.
• do not store in a different container to prevent misuse and preserve quality.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 20mL Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of pouchImage of pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)08806718061010GTIN-14: 08806718061010
GTIN-13: 8806718061010
EAN-13: 8806718061010
GTIN storage (14 digits): 08806718061010
nose pouch.jpg
BarcodeEAN-138806718061027GTIN-13: 8806718061027
EAN-13: 8806718061027
GTIN storage (14 digits): 08806718061027
nose carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72460-82072460-820-01

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
5b4d3e49-e47d-4eaa-aac8-ce84a31a043d0f0f6488-0366-4bdf-ad49-cdbdced9d0c92021-06-11WarningsExact identifier
spl set id: 0f0f6488-0366-4bdf-ad49-cdbdced9d0c9

Reported adverse events (FAERS/openFDA)#

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