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Day Time Cold/Flu Relief (Kareway Product, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 177 mL in 1 BOTTLE (67510-0544-6) Label Information
LIQUID 120 mL in 1 BOTTLE (67510-0544-4) Label Information
LIQUID 354 mL in 1 BOTTLE (67510-0544-2) Label Information
LIQUID 295 mL in 1 BOTTLE (67510-0544-0) Label Information

Complete Day Time Cold/Flu Relief Information

  • Active ingredients(in each 15 ml tablespoon)

    Acetaminophen 325mg

    Dextromethorphan HBr 10mg

    Phenylephrine HCl 5mg


  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant


  • Uses

    temporarily relieves common cold/flu symptoms:

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

  • Warnings

    Enter section text here

    Liver warning

    This product contains acetaminophen.  Severe liver damage may occur if adult/child takes

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • adult has 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 phegm(mucus)
    • Persistent or chronic cough as occurs with smoking, asthma, emphysema
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you aretaking 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
    • symptoms get worse or last 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.

    Enter section text here

    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 children even if you do not notice any signs or symptoms.



  • Directions

    • take only as directed-see Overdose warning
    • use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours
      adults and children 12 yrs and over
      30 ml (2 TBSP) every 6 hours
      children 6 to under 12 yrs
      15 ml (1 TBSP) every 4 hours
      children 4 to under 6 yrs
      ask a doctor
      children under 4 yrs
      do not use

  • Other information

    • each tablespoon contains: sodium 50mg
    • store at room temperature

  • Inactive ingredients

    citric acid, FDC red no.40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
    sodium citrate, sucralose, sucrose, xanthan gum


  • PRINCIPAL DISPLAY PANEL

    Daytime Cold/Flu Reliefimage of carton label


  • INGREDIENTS AND APPEARANCE
    DAY TIME COLD/FLU RELIEF 
    acetaminophen, dextromethorphan, phenylephrine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0544
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0544-4 120 mL in 1 BOTTLE
    2 NDC:67510-0544-6 177 mL in 1 BOTTLE
    3 NDC:67510-0544-0 295 mL in 1 BOTTLE
    4 NDC:67510-0544-2 354 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/06/2011
    Labeler - Kareway Product, Inc. (121840057)