Label: COLDAEWON COUGH A- acetaminophen, ephedrine hcl, guaifenesin syrup
- NDC Code(s): 72460-810-01
- Packager: Daewon Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated October 15, 2019
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- ACTIVE INGREDIENT
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
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
- OTHER INFORMATION
- 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 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength xanthan gum (UNII: TTV12P4NEE) glycerin (UNII: PDC6A3C0OX) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color red Score Shape Size Flavor APPLE, MINT, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/01/2019 Labeler - Daewon Pharmaceutical Co., Ltd. (689275501) Registrant - Daewon Pharmaceutical Co., Ltd. (689275501) Establishment Name Address ID/FEI Business Operations Daewon Pharm. Co., Ltd. Hwaseong Factory 688235368 manufacture(72460-810)