Label: MULTI SYMPTOM DAYTIME- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 27, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    nasal congestion
    •
    cough due to minor throat & bronchial irritation
    •
    sore throat
    •
    headache
    •
    minor aches & pains
    •
    fever
  • Warnings

    Liver warning

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

    •
    more than 4 doses 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, see 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
    •
    thyroid disease
    •
    diabetes
    •
    high blood pressure
    •
    trouble urinating due to enlarged prostate gland
    •
    cough that occurs with too much phlegm (mucus)
    •
    persistent or chronic cough as occurs with smoking, asthma, 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 get worse or last 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

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions

    •
    take only as directed - see Overdose Warning
    •
    do not exceed 4 doses per 24 hours

    adults & children 12 years and over

    2 Softgels with water every 4 hours

    children 4 to under 12 years

    ask a doctor

    children under 4 years

    do not use
  • Other information

    •
    store at room temperature
  • Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-952-0050

  • SPL UNCLASSIFIED SECTION


    Distributed by:

    Greenbrier International, Inc.

    Chesapeake, VA 23320

  • PRINCIPAL DISPLAY PANEL - 10 Softgel Carton

    ASSURED

    COMPARE TO ACTIVE INGREDIENTS IN VICKS ®DAYQUIL®

    Multi-Symptom

    DayTime

    Liquid Capsules

    •
    Acetaminophen- Pain Reliever/Fever Reducer
    •
    Dextromethorphan HBr- Cough Suppressant
    •
    Phenylephrine HCl -Nasal Decongestant

    Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, & Nasal congestion

    10 Softgels

    COMPARE TO ACTIVE INGREDIENT IN VICKS DAYQUIL®

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    *This product is not manufactured or distributed by Procter & Gamble distributor of Vicks®DayQuil® Cold &Flu LiquiCaps®

    Multi-Symptom Daytime Liquid Capsules 10 Softgels
  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-6110
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 512
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-6110-11 in 1 CARTON01/18/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/18/2018
    Labeler - Greenbrier International, Inc. (610322518)
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