DAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [NAVARRO DISCOUNT PHARMACIES,LLC]

DAY TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [NAVARRO DISCOUNT PHARMACIES,LLC]
PDF | XML

NDC 59970-077-12
Set ID c3ccd1be-ccc2-4a52-9092-9b6dfb0ed68a
Category HUMAN OTC DRUG LABEL
Packager Navarro Discount Pharmacies,LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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:

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

    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, 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.

    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 are

    taking the blood thinning drug warfarin.

    When using this product, do not exceed the recommended dosage.


    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

    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 over2 GelCaps with water every 4 hrs
      children 4 to under 12 yrsask a doctor
      children under 4 yrsdo not use
  • Other information

    • store at room temperature
  • Inactive ingredients

    FDC red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobitol special

  • PRINCIPAL DISPLAY PANEL

    Daytime gelcapimage of carton labelback of carton

  • INGREDIENTS AND APPEARANCE
    DAY TIME GELCAP 
    acetaminophen, dextromethorphan, phenylephrine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-077
    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 RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize24mm
    FlavorImprint Code DYTIME
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-077-121 in 1 BOX
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/18/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)

Related Drugs