Label: DAY TIME COLD/FLU RELIEF- acetaminophen, dextromethorphan, phenylephrine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 11, 2012

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  • 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 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
    • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0544
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0544-4120 mL in 1 BOTTLE
    2NDC:67510-0544-6177 mL in 1 BOTTLE
    3NDC:67510-0544-0295 mL in 1 BOTTLE
    4NDC:67510-0544-2354 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/06/2011
    Labeler - Kareway Product, Inc. (121840057)
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