Label: CETAFEN COUGH AND COLD- cold medicine tablet

  • NDC Code(s): 50332-0129-4, 50332-0129-7
  • Packager: HART Health
  • 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 June 5, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet):

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose:

    Pain Reliever/Fever Reducer

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves these cold/flu symptoms

    • cough
    • sore throat
    • headache
    • minor aches and pains
    • nasal congestion
    • helps loosen phlegm (mucus) and bronchial secretions to make coughs more productive

    Temporarily reduces fever

  • WARNINGS

    Warnings:

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions.

    Symptoms may include:

    • skin reddening
    • blisters
    • rash

    Sore throat warning:

    If sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor right away.

  • DO NOT USE

    Do not use

    • with any other product containing acetaminophen (prescription or non-prescription)
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions, or Pakinson's disease), or for 2 weeks after stopping the MAOI drug or if you do not know if your prescription drug contains an MAO.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if 

    • you are taking the blood thinning drug warfarin
    • you do not know if other drugs you are taking contain acetaminophen
  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart, liver or thyroid desease
    • high blood pressure
    • diabetes or glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • new symptoms occur
    • you get nervous, dizzy, or sleepless
    • pain, nasal congestion or cough gets worse or last for more than 7 days
    • redness or swelling is present
    • fever gets worse or lasts for more than 3 days
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose wasrning:

    Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or call a Poison Control Center right away. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions:

    Do not take more than directed.

    Adults and children 12 years of age and over:

    • take 2 tablets every 6 to 8 hours while symptoms persist.
    • do not take more than 8 tablets in 24 horus unless directed by a doctor

    Children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    5581CetafenCoughv19f.jpg5581CetafenCoughv19f.jpg5581CetafenCoughv19f.jpg

  • INGREDIENTS AND APPEARANCE
    CETAFEN COUGH AND COLD 
    cold medicine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0129-450 in 1 BOX, UNIT-DOSE03/14/2007
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0129-7125 in 1 BOX, UNIT-DOSE03/14/2007
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/14/2007
    Labeler - HART Health (069560969)