Label: DAYTIME NON-DROWSY COLD/FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

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

Drug Label Information

Updated December 29, 2023

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

  • Drug FactsActive Ingredients (in each 15 mL, 1 tablespoon)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCL 5 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • INDICATIONS & USAGE

    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

    Warnings
    Liver Warning: The product contains acetaminophen. Severe liver
    damage may occur if ■ adult takes more than 4doses (30 mL each)
    in 24 hours, which is the maximum daily amount for this product ■
    child takes more than 4 doses (15 mL each) in 24 hours, which is the
    maximum daily amount for this product ■ taken with other drugs
    containing acetaminophen ■ adult has 3 or more alcoholic drinks
    every day while using the 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

    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 two weeks after stopping

    the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a

    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 pharmacists.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have • liver disease • heart disease •thyroid disease

    • diabetes • high blood pressure • trouble urinating due to enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)

    Ask a doctor or pharmacist before use  if the user is taking the blood thinning drug warfarin

  • WHEN USING

    When using this product •do not use more than directed (see overdose warning) • avoid alcoholic drinks

  • STOP USE

    Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur
    ● fever gets worse or lasts more than 3 days
    ● pain or cough gets worse or lasts more than 5 days (children) or
    7 days (adults) • 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 of breast-feeding ask a health profesional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • OVERDOSAGE

    Overdose Warning: Taking more than the recommended dose (overdose)
    could cause serious health problems, including liver damage. In case of
    accidental overdose, seek professional assistance or contact a Poison
    Control Center immediately. 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 recommended (see overdose warning)

    • use dosage cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours

                     age                                                        dose

    adults and children 12 years and over             30 mL (2 TBSP) every 4 hours

    children 6 years to under 12 years                 15 mL (1 TBSP) every 4 hours

    children 4 years to under 6 years                   ask a doctor

    children under 4 years                                 do not use

    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
  • OTHER SAFETY INFORMATION

    Other information

    • sodium content per tablespoon: 10 mg
    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified

    water, saccharin sodium, sodium benzoate, sucrose

  • Day Time product label

    COMPARE TO

    VICKS® DAYQUIL®

    ACTIVE INGREDIENTS

    CVP®

    DAY TIME

    NON-DROWSY COLD/FLU RELIEF

    Acetaminophen……Pain Reliever/Fever Reducer
    Dextromethorphan HBr……Cough Suppressant
    Phenylephrine HCL ……. Nasal Decongestant

    6 FL OZ (177 mL)

    Failure to follow these warnings could result in serious consequences

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

    *This product is not manufactured or
    distributed by Proctor and Gamble, owner of
    the registered trademark Vicks® Dayquil®.

    Questions? Call weekdays from 9:30am
    to 4:30pm EST at 1-877-798-5944

    LR-038 Rev 03

    Distributed by:
    Salado Sales, Inc.
    P.O. Box 6115
    Temple, Tx 76503

    www.saladosales.com

    LOT:       EXP:

    CVP 506-25

    RES

  • INGREDIENTS AND APPEARANCE
    DAYTIME  NON-DROWSY COLD/FLU
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-506
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-506-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product09/05/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/05/2012
    Labeler - Salado Sales, Inc. (009830555)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(57243-506)