Label: COLD AND FLU DAYTIME NIGHTTIME SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

  • NDC Code(s): 0363-4278-45, 0363-8078-45, 0363-9042-45
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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  • Active ingredients (in each 20 mL) (Daytime Cold & Flu)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg 

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Active ingredients (in each 20 mL) (Nighttime Severe Cold & Flu)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Phenylephrine HCl 10 mg
    Triprolidine HCl 2.5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant
    Antihistamine

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • sore throat
      • nasal congestion
      • stuffy nose
      • minor aches and pains
      • sneezing (Nighttime only)
      • headache
      • cough
      • runny nose (Nighttime only)
      • itching of the nose or throat (Nighttime only)
      • itchy, watery eyes due to hay fever (Nighttime only)
      • sinus congestion and pressure
    • temporarily reduces fever
    • controls cough to help you get to sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • diabetes
    • thyroid disease
    • heart disease
    • glaucoma (Nighttime only)
    • difficulty in urination due to enlargement of the prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
    • high blood pressure

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nighttime only)

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
    • avoid alcoholic beverages (Nighttime only)
    • use caution when driving a motor vehicle or operating machinery (Nighttime only)

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • 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.

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

    Do not take DAYTIME and NIGHTTIME products at the same time.

  • Directions (Daytime only)

    • do not take more than directed
    • do not take more than 6 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
    • children under 12 years: do not use
  • Directions (Nighttime only)

    • do not take more than directed
    • do not take more than 4 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
    • children under 12 years: do not use
  • Other information

    • each 20 mL contains: sodium 10 mg (Daytime only)
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients (Daytime only)

    anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

  • Inactive ingredients (Nighttime only)

    anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions?

    Call 1-800-910-6874

  • Principal display panel

    DAY & NIGHT PACK
    NDC 0363-4278-45

    Walgreens
    • WALGREENS •
    PHARMACIST RECOMMENDED†
    Compare to the active ingredients in Maximum
    Strength Mucinex® FAST-MAX® Cold & Flu
    & NIGHTSHIFT® Severe Cold & Flu††
    DAYTIME
    Cold & Flu

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    GUAIFENESIN / EXPECTORANT
    PHENYLEPHRINE HCl / NASAL DECONGESTANT

     

    Maximum Strength

    • Relieves headache, body pain,
      sore throat, fever, chest congestion,
      cough, nasal congestion,
      sinus congestion & pressure
    • 12 years & older

     

     

     

     

     

    NIGHTTIME
    Severe
    Cold & Flu

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    PHENYLEPHRINE HCl / NASAL DECONGESTANT
    TRIPROLIDINE HCl / ANTIHISTAMINE

    Maximum Strength

    • Relieves headache, body pain,
       sore throat, fever, itchy throat, cough,
       nasal congestion, runny nose & sneezing
    • 12 years & older

    2 – 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING
    Do not take Daytime Cold & Flu and Nighttime
    Severe Cold & Flu at the same time.

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    DISTRIBUTED BY: WALGREEN CO.
    DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2023 Walgreen Co.

    †Our pharmacists recommend the Walgreens brand.
    We invite you to compare to national brands.
    ††This product is not manufactured or distributed by RB Health (US) LLC, owner
    of the registered trademarks Maximum Strength Mucinex® FAST-MAX® Cold &
    Flu and NIGHTSHIFT® Severe Cold & Flu.

    44-042078

    Walgreens 44-042078


  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  DAYTIME NIGHTTIME SEVERE
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4278
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4278-451 in 1 PACKAGE; Type 0: Not a Combination Product10/21/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 177 mL
    Part 21 BOTTLE, PLASTIC 177 mL
    Part 1 of 2
    COLD AND FLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Item Code (Source)NDC:0363-9042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBERRY (MIXED) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9042-45177 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 DrugM01210/21/2023
    Part 2 of 2
    COLD AND FLU  SEVERE
    acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl solution
    Product Information
    Item Code (Source)NDC:0363-8078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUIT (MIXED) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8078-45177 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 DrugM01210/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/21/2023
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(0363-4278) , pack(0363-4278)
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