Label: COLD AND FLU DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

  • NDC Code(s): 63868-736-24
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethoprhan HBr 10 mg

    Phenlyephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • fever
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

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

    Allery 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

    • 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.
    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if the user has

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

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    When using this product,

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • nervousness, dizziness, or sleeplessness occur
    • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    • do not take more than directed (see overdose warning)
    • do not take more than 4 doses in 24-hour period
    • adults and children 12 years and over: take 2 softgels with water every 4 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing
  • Other information

    • store between 15-30ºC (59-86º)
    • avoid excessive heat
  • Inactive ingredients

    FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white ink


  • Questions or comments?

    Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS®

    Non-Drowsy

    Day Time 

    Multi-Symptom Relief For Cold/Flu

    Acetaminophen,  Dextromethorphan HBr, Phenylephrine HCl

    Pain Reliever | Fever Reducer

    Cough Suppressant | Nasal Decongestant

    Non-Drowsy | Alcohol Free | Antihistamine Free

    Softgels

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

    Distributed by C.D.M.A., Inc©

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

  • Package Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

    QUALITYCHOICE Non-Drowsy Day Time Cold and Flu Relief

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  DAYTIME
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-736
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITAN (UNII: 6O92ICV9RU)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code PC9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-736-2424 in 1 CARTON04/30/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/30/2021
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)