Label: DAYTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

  • NDC Code(s): 63868-467-24
  • Packager: Chain Drug Marketing Association, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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

  • Drug Facts

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purposes

    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 passageways of bothersome mucus and make some coughs more productive

  • Warnings

    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

    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 gets worse or lasts 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.

    Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. 

  • Directions

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

    adults & children

    12 yrs & over

    2 softgels with water

    every 4 hours 

    children 4 to under

    12 yrs

    ask a doctor 
    children under 4 yrsdo not use

  • Other information

    •  store at 20-25°C (68-77ºF)   •  protect from light, heat and moisture

  • Inactive ingredients

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

  • Questions?

    Call toll free: 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredients in Vicks® DayQuil™ Severe Cold & Flu Relief LiquiCaps™*

    Temporarily relieves common cold/flu symptoms:
    aches, fever and sore throat
    controls cough
    nasal and chest congestion
    thins and loosens mucus

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Procter & Gamble Company, owner of the registered trademarks Vicks®, DayQuil™.

    100% QC SATISFACTION GUARANTEED

    Distributed by CDMA, Inc.
    43157 W Nine Mile
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

    Product of India
    Packaged and Quality Assured in the USA

  • Packaging

    Label-467

  • INGREDIENTS AND APPEARANCE
    DAYTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-467
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (oblong) Size20mm
    FlavorImprint Code 782
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-467-242 in 1 CARTON05/03/2022
    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 DrugM01205/03/2022
    Labeler - Chain Drug Marketing Association, Inc. (011920774)