SUNMARK DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MCKESSON]

SUNMARK DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MCKESSON]
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NDC 49348-753-36, 49348-753-37
Set ID b859400f-c649-49c3-b5b9-6310c1e78274
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 15 mL)

    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

    adult takes more than 4,000 mg of acetaminophen in 24 hours
    child takes more than 5 doses in 24 hours
    taken with other drugs containing acetaminophen
    adult has 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, persists 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
    thyroid disease
    diabetes
    high blood pressure
    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 5 days (children) or 7 days (adults)
    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
    only use the dose cup provided
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 4 hrs

    children 6 to under 12 yrs

    15 mL every 4 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    each 15 mL contains: sodium 7 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

    day time

    Cold & Flu

    Pain Reliever/Fever Reducer

    Cough Suppressant

    Nasal Decongestant

    Acetaminophen

    Phenylephrine HCl

    Dextromethorphan HBr

    Non-Drowsy - Alcohol Free

    MULTI-SYMPTOM RELIEF

    GLUTEN FREE

    8 FL OZ (237 mL)

    Day Time Cold & Flu Image 1
    Day Time Cold & Flu Image 2
  • INGREDIENTS AND APPEARANCE
    SUNMARK DAY TIME  COLD AND FLU
    acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-753
    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) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGE (clear) Score    
    ShapeSize
    FlavorMENTHOL (with fruit) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-753-36177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/200605/14/2013
    2NDC:49348-753-37237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/06/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/09/2006
    Labeler - Strategic Sourcing Services LLC (116956644)