Label: COLDAEWON COLD A- acetaminophen, chlorpheniramine maleate, ephedrine hcl, guaifenesin syrup

  • NDC Code(s): 72460-800-01
  • 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.

Drug Label Information

Updated October 15, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Active ingredients (in each 20 mL pouch) Purpose

    Acetaminophen 300 mg

    Chlorpheniramine Maleate 2.5 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
    - Antihistamine/immunosuppressant
    - 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? 1-562-281-5888

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 20mL Pouch

    Image of pouch

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton

    Image of carton

  • INGREDIENTS AND APPEARANCE
    COLDAEWON COLD A 
    acetaminophen, chlorpheniramine maleate, ephedrine hcl, guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72460-800
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN300 mg  in 20 mL
    Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) Guaifenesin42 mg  in 20 mL
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE18 mg  in 20 mL
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) Chlorpheniramine Maleate2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    xanthan gum (UNII: TTV12P4NEE)  
    glycerin (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorLEMON, MINT, APPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72460-800-015 in 1 CARTON06/01/2019
    120 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/2019
    Labeler - Daewon Pharmaceutical Co., Ltd. (689275501)
    Registrant - Daewon Pharmaceutical Co., Ltd. (689275501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daewon Pharm. Co., Ltd. Hwaseong Factory688235368manufacture(72460-800)