Label: ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 18, 2019

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

  • ACTIVE INGREDIENT

    Acetaminophen 325mg

    Dextromethorphan HBr 10mg

    Guaifenesin 200mg

    Phenylephrine HCl 5mg

  • PURPOSE

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • INACTIVE INGREDIENT

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • DOSAGE & ADMINISTRATION

    • Take only as directed (See overdose warning)
    • Do not exceed 4 doses per 24-hours
    • Adults and children 12 years and over: take 2 softgels with water every 4 hours
    • Children 4 to under 12 years: ask a doctor
    • When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

  • INDICATIONS & USAGE

    Temporarily relieves common cold/flu symptoms:

    • Nasal congestion
    • Sinus congestion & pressure
    • Cough due to minor throat & bronchial irritation
    • Minor aches & pain
    • Headache
    • Fever
    • Sore throat
    • Reduces swelling of nasal passages
    • Temporarily restore freer breathing through the nose
    • Promotes nasal and/or sinus drainage
    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains 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

    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 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 contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have:

    Liver disease
    High blood pressure
    Thyroid disease
    Diabetes
    Trouble urinating due to enlarged prostate gland
    Cough that occurs with too much phlegm (mucus)
    Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    When using this product, do not use more than directed.

    Stop use and ask a doctor if:

    You get nervous, dizzy, or sleepless
    Pain, nasal congestion, or cough gets worse or lasts more than 7 days
    Fever gets worse or last more than 3 days
    Redness or swelling is present
    New symptoms occur
    Cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

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

    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    OVERDOSE WARNING: Read directions carefully. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • OTHER SAFETY INFORMATION

    store at room temperature between 20-25°C (68-77ºF)

    avoid excessive heat and humidity

  • PRINCIPAL DISPLAY PANEL

    COLDTAC

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 
    acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-782
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POVIDONE K30 (UNII: U725QWY32X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colororange (LIGHT ORANGE) Scoreno score
    ShapeOVAL (Oblong) Size20mm
    FlavorImprint Code 782
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-782-1010 in 1 BLISTER PACK; Type 0: Not a Combination Product02/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/18/2019
    Labeler - OPMX LLC (029918743)