Label: WAG HBP DAYTIME AND NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate kit

  • NDC Code(s): 0363-6219-16, 0363-6220-16, 0363-6221-16
  • Packager: WALGREENS CO.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    HBP Nighttime Cold & Flu

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 30 mg
    Doxylamine succinate 12.5 mg


    Pain reliever/ fever reducer
    Cough suppressant
    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    ▪
    cough due to minor throat & bronchial irritation
    ▪
    sore throat
    ▪
    headache
    ▪
    minor aches & pains
    ▪
    fever
    ▪
    runny nose and sneezing
  • Warnings

    See carton for complete warnings

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    ▪
    take only as directed
    ▪
    only use the dose cup provided
    ▪
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    ▪
    each 30 mL contains: sodium 16 mg
    ▪
    store at room temperature
  • Inactive ingredients

    Anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, propylene glycol, Propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    Distributed by:

  • SPL UNCLASSIFIED SECTION

    HBPDaytime Cold & Flu Relief

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg

    Purpose

    Pain reliever/Fever reducer
    Cough suppressant

  • Uses

    temporarily relieves common cold/flu symptoms:

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

    See carton for complete warnings

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away at1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    take only as directed
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    •
    each 15 mL contains: sodium 46 mg
    •
    store at room temperature and do not refrigerate.
  • Inactive ingredients

    Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propylene glycol, purified water, , sodium benzoate, sorbitol, sucralose

  • Questions?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    VALUE PACK

    High Blood Pressure

    Daytime

    COLD & FLU

    Acetaminophen, Dextromethorphan HBr

    •
    Headache, Fever, Sore Throat
    •
    Minor Aches & Pains
    •
    Cough

    Daytime 8 FL OZ (236 ml) BOTTLE

    High Blood Pressure

    Nighttime

    COLD & FLU

    Nighttime Relief

    Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

    •
    Headache, Fever, Sore Throat
    •
    Minor Aches & Pains
    •
    Sneezing, Runny Nose
    •
    Cough

    Sugar Free & No Added Alcohol

    Nighttime 8 FL OZ (236 ml) BOTTLE

    TOTAL 16 FL OZ (472 ml)

    WAG HBP Daytime and Nightttime Cold and Flu Value Pack
  • INGREDIENTS AND APPEARANCE
    WAG HBP DAYTIME AND NIGHTTIME  COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6220
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6220-161 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 236 mL
    Part 21 BOTTLE, PLASTIC 236 mL
    Part 1 of 2
    WALGREEN HBP DAYTIME  COLD AND FLU MULTI-SYMPTOM RELIEF
    acetaminophen, dextromethorphan hydrobromide liquid
    Product Information
    Item Code (Source)NDC:0363-6219
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6219-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/10/2023
    Part 2 of 2
    WALGREEN HBP NIGHTTIME  COLD AND FLU NIGHTTIME RELIEF
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:0363-6221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6221-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/10/2023
    Labeler - WALGREENS CO. (008965063)
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