Label: ACETAMINOPHEN, DEXTROMETHORPHAN HBR capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 6, 2026

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

  • Active Ingredients (in each softgel)

    Acetaminophen 325 mg ........................................ Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg ......................... Cough suppressant

  • Purpose

    Acetaminophen 325 mg ........................................ Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg ......................... Cough suppressant

  • Uses

    Temporarily relieves common cold and flu symptoms:
    • Minor aches and pains
    • Headache
    • Sore throat
    • Fever
    • Cough due to minor throat and bronchial irritation

  • Warnings

    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.

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:
    • More than 8 softgels 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

    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.

  • DO NOT USE

    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.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use 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 DOCTOR

    Ask a doctor before use if you have:
    • liver disease
    • diabetes
    • heart disease
    • thyroid disease
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)

  • WHEN USING

    When using this product
    • Do not exceed recommended dosage.

  • ASK DOCTOR/PHARMACIST

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

  • STOP USE

    Stop use and ask a doctor if
    • Pain, cough, or nasal congestion gets worse or lasts more than 7 days.
    • New symptoms occur.
    • Nervousness, dizziness, or sleeplessness occur.
    • Fever gets worse or lasts more than 3 days.
    • Redness or swelling is present.
    • 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 warning: 
    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Take only as directed-see OVERDOSE WARNING.
    Do not exceed 8 softgels per 24 hours.

     Adults & children 12 years and over Take 2 softgels with water every 4 hours
     Children 4 to under 12 years Ask a doctor
     Children under 4 years Do not use

  • Other information

    • Store at room temperature between 20°–25°C (68°–77°F).
    • Avoid excessive heat, cold, and humidity.

  • Inactive ingredients

    Polyethylene Glycol-400, Propylene Glycol, Povidone (PVPK-30), FD & C Red No. 40, FD & C Yellow No. 6, Purified Water, Gelatin, Glycerin, Sorbitol Sorbitan Solution.

  • Questions or comments?

    Call 1 (718) 337-8733 or email: support@nuvicare.com

  • NDC 84324-036-01

    DAYTIME COLD & FLU (2)

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DEXTROMETHORPHAN HBR 
    acetaminophen, dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-036
    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 HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (Oblong) Size17mm
    FlavorImprint Code BZ10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84324-036-011 in 1 CARTON06/17/2026
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/17/2026
    Labeler - NUVICARE LLC (119257565)