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

  • NDC Code(s): 68016-236-08, 68016-236-12
  • Packager: Pharmacy Value Alliance, LLC
  • 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.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    (in each 15mL, 1tablespoon)
    Acetaminophen           325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI        5mg

  • PURPOSE

    Purpose
    Acetaminophen             Pain reliever/fever reducer
    Dextromethorphan HBr   Cough suppressant
    Phenylephrine HCI         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: This product contains acetaminophen. Severe liver
    damage may occur if adult/child takes:
    • more than 4doses in 24 hours, which is the maximum daily amount
    for this product • with other drugs containing acetaminophen
    • 3or more alcoholic drinks everyday 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
    2days, 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

    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 DOCTOR/PHARMACIST

    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 3days
    • pain or cough gets worse or lasts more than 5days (children) or
    7days (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 or breast-feeding ask a health professional before
    use. 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.

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

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

  • DOSAGE & ADMINISTRATION


    Directions
    • take only as recommended (see overdose warning) • use dosage
    cup or tablespoon (TBSP) • do not exceed 4doses per 24 hours

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

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

    children 4 years to            ask a doctor
    under 6 years

    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

  • OTHER SAFETY INFORMATION

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

  • INACTIVE INGREDIENT

    Inactive ingredients
    citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol
    purified water, saccharin sodium, sodium benzoate, sucrose

  • QUESTIONS

    Questions?Call weekdays 1-877-798-5944.
    *This product is not manufactured or distributed by Proctor &
    Gamble, owner of the registered trademark Vicks® NyQuil®.
    DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
    407 EAST LANCASTER AVENUE, WAYNE PA 19087

    If for any reason you are not satisfied with this product, please
    return It to the store where purchased for a full refund.

  • Principal Display Panel

    Premier® Value

    COMPARE TO THE ACTIVE

    INGREDIENTS IN

    VICKS® DAYQUIL®*

    COLD & FLU
    Day Time Multi-Symptom Relief

    Acetaminophen...... Pain Reliever/Fever Reducer
    Dextromethorphan Hsr...... Cough Suppressant
    Phenylephrine HCI........Nasal Decongestant

    Non-drowsy

    8 FL OZ (237 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    Questions? Call weekdays 1-877-798-5944.
    *This product is not manufactured or distributed by Proctor &
    Gamble, owner of the registered trademark Vicks® NyQuil®.
    DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
    407 EAST LANCASTER AVENUE, WAYNE PA 19087

    If for any reason you are not satisfied with this product, please
    return It to the store where purchased for a full refund.

    LR-028

    REV-01

    Product Label - 8 FL OZ

    236-08

    Product Label - 12 FL OZ

    236-12

                                                                      Premier Value Cold & Flu Day Time Multi-Symptom Relief

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-236
    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) PHENYLEPHRINE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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:68016-236-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    2NDC:68016-236-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2018
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-236)