Label: DAY TIME MULTI-SYMPTOM COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hcl capsule, liquid filled

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

Drug Label Information

Updated November 17, 2023

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

  • ACTIVE INGREDIENT

    Drug Facts


    Active ingredients (in each Softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI 5 mg

  • PURPOSE

    Purpose
    Acetaminophen                    Pain reliever/Fever reducer
    Dextromethorphan HBr        Cough suppressant
    Phenylephrine HCI               Nasal Decongestant

  • INDICATIONS & USAGE

    Uses
    temporarily relieves common cold and flu symptoms:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pain
    • fever

  • WARNINGS

    Warnings
    Liver warning: This product contains
    acetaminophen. Severe liver damage may occur if you take:
    • more than 8 Liquid Caps in 24 hours • which is the maximum daily
    amount for this product • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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, lasts for more than
    2 days, occurs with or is 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
    • 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 • heart
    disease • thyroid disease • diabetes • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma or
    emphysema

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the

    blood thinning drug warfarin.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless
    • symptoms get worse or last 1) more than 5 days (children) or 7
      days (adults)
    • 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.

  • 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.
    In case of accidental 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • take only as directed (see Warning)
    • do not exceed 4 doses per 24 hours

     adults and Children 12 yrs & over 2 softgels with water every 4 hours
     children 4 to under 12 yrs ask a doctor
     children under 4 years do not use

    when using olher Daytime or Nighttime producls,
       carefully read each label to ensure correcl dosing

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature 20-2S·C (68-77"F)
    • avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredientsFD&C Red #40, FD&C Yellow #06,

    gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,

    Purified water, Sorbitol sorbitan solution, Titanium dioxide.

  • QUESTIONS

    Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Package Labeling: DISCOUNT drug mart Day Time Multi-Symptom Cold & Flu Relief

    60403 Box

    DISCOUNT                                                                  NDC-53943-604-03

    drug mart

    FOOD MARKET

    Cold &
    Flu Relief

    MULTI-SYMPTOM

    DAY TIME

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

    24 Softgels

    DISTRIBUTED BY:

    DRUG MART - FOOD FAIR

    211 COMMERCE DRIVE

    MEDINA, OH 44256

    www.discount-drugmart.com

    This product is not manufactured or distributed by Procter
    & Gamble, owner of the registered trademark Vicks®
    DayOuilTM LiquiCapsTM

    TAMPER EVIDENT: DO NOT USE IF

    PACKAGE IS OPENED OR BLISTER

    UNIT IS TORN, BROKEN OR SHOWS

    ANY SIGNS OF TAMPERING

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE

    WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON

    FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO:

    DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINA, OHIO 44256

  • INGREDIENTS AND APPEARANCE
    DAY TIME MULTI-SYMPTOM COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-604
    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 RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 604
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-604-032 in 1 CARTON11/08/2023
    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 DrugM01211/08/2023
    Labeler - Discount Drug Mart (047741335)