MULTI-SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]

MULTI-SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]
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NDC 68210-0104-1
Set ID 33cbb648-cbd8-4c14-b6ec-23c41ece0f1e
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan Hydrobromide 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal 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 every day while using this product

    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 gets 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 and 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 and children 12 years of age and overswallow 2 softgels with water every 4 hours
    children 4 to under 12 years of ageask a doctor
    children under 4 years of agedo not use

    If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

  • Other information

    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
    • this product does not contain phenylpropanolamine
  • Inactive ingredients

    FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton

    COMPARE TO ACTIVE INGREDIENTS IN
    VICKS ® DAYQUIL ®*

    ASSURED

    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

    Actual Size

    10 softgels

    PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0104
    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 YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULE (SOFTGELS) Size21mm
    FlavorImprint Code 512
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0104-11 in 1 CARTON02/20/2016
    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 finalpart34102/20/2016
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LTD677385498manufacture(68210-0104)

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