MULTI SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]

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  • MULTI SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]

MULTI SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]
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NDC 33992-6110-1
Set ID c2cbc647-e5d9-43c7-9f6c-b808032191c5
Category HUMAN OTC DRUG LABEL
Packager Greenbrier International, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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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