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

  • NDC Code(s): 35916-0166-1
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 29, 2024

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

  • Active ingredients (in each Softgel)

    Acetaminophen USP 325 mg

    Dextromethorphan HBr USP 10 mg

    Guaifenesin USP 200 mg

    Phenylephrine HCl USP 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways 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 8 softgels in 24 hrs, 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:

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

  • Ask a doctor before use if you have

    • liver disease
    • heart 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 get worse or last more than 7 days
    • fever gets worse or lasts 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.

    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.

  • Directions

    • take only as directed
    • do not exceed 8 softgels per 24 hrs

    adults & children 12 years & over2 softgels with water every 4 hours
    children 4 to under 12 yearsask a doctor
    children under 4 yearsdo not use

  • Other information

    • store at no greater than 25 ° C
  • Inactive ingredients

    FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • PRINCIPAL DISPLAY PANEL

    MAX STRENGTH

    NDC 35916-0166-1

    Compared to the active ingredient in Vicks® DayQuil ™ severe COLD & FLU LiquiCaps™

    Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine HCl 5mg And Dextromethorphan HBr 10mg Softgelatin Capsules

    Headache, Fever, Sore throat, Minor aches & Pains

    Chest congestion, Thins & loosen mucus

    Nasal congestion, Sinus Pressure

    cough

    24 Softgels

    Day Time Severe Cold & Flu

    (Non-Drowsy)

    Day time Severe

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR 
    acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    Colororange (Transparent) Scoreno score
    ShapeCAPSULE (oblong square) Size21mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0166-12 in 1 CARTON10/29/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/29/2024
    Labeler - Softgel Healthcare Pvt Ltd (675584180)