Home > Pill Identifier > APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 5 MG Oral Capsule

Pill Identifier Information of APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 5 MG Oral Capsule

Drug Information

APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 5 MG Oral Capsule

Imprint: NYTIME
Shape: C48336
Color: C48329
Ingredients: Acetaminophen; Dextromethorphan; Doxylamine
Size: 24.00
Score: 1
Rxtty: SY
Author: Kareway Product, Inc.
Inactive Ingredients: FD&C BLUE NO. 1 / FD&C YELLOW NO. 5 / GELATIN / GLYCERIN / POLYETHYLENE GLYCOL 400 / POVIDONE / PROPYLENE GLYCOL, (R)- / WATER / SORBITOL>

Complete Information

  • Active ingredients(in each GelCap)

    Acetaminophen 325mg

    Dextromethorphan HBr 15mg

    Doxylamine succinate 6.25mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
  • 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, 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.
    • to make a child sleep

    Ask a doctor before use if you have
    • liver disease
    • glaucoma
    • cough that occurs with too much phegm(mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are
    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    Enter section text here

    Stop use and ask a doctor if
    • pain or cough gets worse or lasts more than 7 days
    • 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 yellow no. 5, dioxide, FDC blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special

  • PRINCIPAL DISPLAY PANEL

    Pure-Aid Nighttime Gelcapimage of carton

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME GELCAP 
    acetaminophen, dextromethorphan, doxylamine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0521
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize24mm
    FlavorImprint Code NYTIME
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0521-11 in 1 BOX
    110 in 1 BLISTER PACK
    2NDC:67510-0521-21 in 1 BOX
    212 in 1 BLISTER PACK
    3NDC:67510-0521-02 in 1 BOX
    320 in 1 BLISTER PACK
    4NDC:67510-0521-42 in 1 BOX
    424 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2011
    Labeler - Kareway Product, Inc. (121840057)
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