COLDAEWON COUGH A- acetaminophen, ephedrine hcl, guaifenesin syrup

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 20 mL pouch)

Acetaminophen 300 mg
Ephedrine HCl 18 mg
Guaifenesin 42 mg
INACTIVE INGREDIENT

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

Purpose:
- Pain reliever/fever reducer
- Nasal decongestant
- Expectorant
WARNINGS

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

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

Uses temporarily relieves common cold/flu symptoms:
runny nose sneezing nasal congestion sore throat cough due to minor throat and bronchial irritation fever headache minor pains and aches
Directions

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 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.
QUESTIONS

Questions? 82-2-2204-7000 www.daewonpharm.com/en/
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 20mL Pouch
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton

INGREDIENTS AND APPEARANCE

COLDAEWON COUGH A
acetaminophen, ephedrine hcl, guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72460-810
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	300 mg in 20 mL
Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	Guaifenesin	42 mg in 20 mL
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE HYDROCHLORIDE	18 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
xanthan gum (UNII: TTV12P4NEE)
glycerin (UNII: PDC6A3C0OX)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	APPLE, MINT, LEMON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72460-810-01	5 in 1 CARTON	06/01/2019
1		20 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/01/2019

Labeler - Daewon Pharmaceutical Co., Ltd. (689275501)

Registrant - Daewon Pharmaceutical Co., Ltd. (689275501)

Name	Address	ID/FEI	Business Operations
Establishment
Daewon Pharm. Co., Ltd. Hwaseong Factory		688235368	manufacture(72460-810)

COLDAEWON COUGH A- acetaminophen, ephedrine hcl, guaifenesin syrup

ColdaeWon Cough A by

Drug Labeling and Warnings

Drug Details [pdf]