GOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]

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  • GOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]

GOOD SENSE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]
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NDC 0113-0994-51, 0113-0994-53, 0113-0994-60, 0113-0994-62, 0113-0994-73
Set ID 5ddf3283-94e4-465d-842a-471ee946c330
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

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

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

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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.
    •
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    •
    liver disease
    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an 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 gets worse or lasts 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as 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 hrs

    adults & children 12 yrs & over

    2 softgels with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Inactive ingredients

    edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Multi-Symptom Relief

    GREAT SIZE FOR TRAVEL

    Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

    Non-Drowsy

    DayTime

    Cold & Flu

    Actual Size

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Nasal Congestion

    Cough

    Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

    Compare to active ingredients of Vicks® DayQuil® Cold & Flu

    100% SATISFACTION GUARANTEED

    8 Softgels

    Powerful Non-Drowsy Relief

    994C2-daytime
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE DAYTIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0994
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code L994
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0994-536 in 1 CARTON09/01/201005/30/2014
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0113-0994-6010 in 1 CARTON01/18/200705/17/2014
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0113-0994-738 in 1 CARTON09/14/2012
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0113-0994-6212 in 1 CARTON09/06/2012
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0113-0994-514 in 1 CARTON08/10/2016
    52 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/18/2007
    Labeler - L. Perrigo Company (006013346)
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