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Day Time Gelcap (Kareway Product, Inc.)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BLISTER PACK in 1 BOX (67510-0523-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 BOX (67510-0523-4) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 1 BLISTER PACK in 1 BOX (67510-0523-2) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 BOX (67510-0523-0) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete Day Time Gelcap Information

  • Active ingredients(in each GelCap)

    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 you take

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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

    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 to adults and 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 yrs and over
      2 GelCaps with water every 6 hrs
      children 4 to under 12 yrs
      ask a doctor
      children under 4 yrs
      do not use

  • Other information

    • store at room temperature

  • Inactive ingredients

    FDC red no. 40, FDC yellow no. 5, dioxide, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special


  • PRINCIPAL DISPLAY PANEL

    Daytime gelcapimage of carton label


  • INGREDIENTS AND APPEARANCE
    DAY TIME GELCAP 
    acetaminophen, dextromethorphan, phenylephrine capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0523
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color orange Score no score
    Shape CAPSULE Size 24mm
    Flavor Imprint Code DYTIME
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0523-1 1 in 1 BOX
    1 10 in 1 BLISTER PACK
    2 NDC:67510-0523-2 1 in 1 BOX
    2 12 in 1 BLISTER PACK
    3 NDC:67510-0523-0 2 in 1 BOX
    3 20 in 1 BLISTER PACK
    4 NDC:67510-0523-4 2 in 1 BOX
    4 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/01/2011
    Labeler - Kareway Product, Inc. (121840057)