Label: DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION- brompheniramine maleate, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit

  • NDC Code(s): 51316-916-03, 51316-919-03, 51316-939-04
  • Packager: CVS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 3, 2025

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  • ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL)

    Brompheniramine Maleate 1 mg 

    Dextromethorphan HBr 5 mg 

    Phenylephrine HCI 2.5 mg 

  • ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 5 mL)

    Diphenhydramine HCI 6.25 mg

    Phenylephrine HCI 2.5 mg 

  • PURPOSE FOR DAYTIME

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • PURPOSE FOR NIGHTTIME

    Antihistamine / Cough suppressant

    Nasal Decongestant

  • USE(S)


    DAYTIME

    • temporarily relieves cough due to minor
      bronchial irritation as may occur with a cold, and
      nasal congestion due to the common cold, hay
      fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay
      fever (allergic rhinitis): • sneezing • itching of the
      nose or throat • runny nose • itchy, watery eyes
    • temporarily restores freer breathing through the nose

    NIGHTTIME


    • tempuradly relieves these symptoms occuring with
      a cold, hay fever or other upper respiratory allergies:
      • sneezing. itching of the nose or throat. runny nose
      • itchy, watery eyes. cough. nasal congestion
  • WARNINGS

    .

  • DO NOT USE

    Daytime

    Do not use

    • to sedate a child or to make a child sleepy
    • 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.

    Nighttime

    Do not use

    • to sedate a child or to make a child sleepy
    • 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 nut know if your prescription drug contains an MAOI, ask a doctor
      or pharmacist before taking this product.
    • with any other product containing diphenhydramine, even one used on skin
  • ASK A DOCTOR BEFORE USE IF YOU HAVE


    DAYTIME

    • heart disease 
    • glaucoma 
    • diabetes 
    • thyroid disease 
    • high blood pressure
    • difficulty in urination due to an enlarged prostate gland 
    • cough that occurs wilt too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

     
    NIGHTTIME


    • heart disease 
    • glaucoma 
    • diabetes
    • thyroid disease 
    • high blood pressure 
    • difficulty in urination due to an enlarged prostate gland 
    • cough that occurs with too much phlegm (mucus) 
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    DAYTIME

    • taking any other oral nasal decongestant or stimulant 
    • taking sedatives or tranquilizers

     

    NIGHTTIME

    • taking any other oral nasal decongestant or stimulant 
    • taking sedatives or tranquilizers
  • WHEN USING THIS PRODUCT

    DAYTIME 

    • do not take more than directed
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness 
    • avoid alcoholic beverages
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

     NIGHTTIME

    • do not take more than directed
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
  • STOP USE AND ASK DOCTOR IF

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

  • DIRECTIONS


    DAYTIME

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dosage
    • mL milliliter
    • tsp = teaspoon

    Age Dose  
    adults & children 12 years over 
    		 4 tsp (20 mL) every 4 hours
    children 6 years to under 12 years
    		 2 tsp (10 mL) every 4 hours
    children under 6 years do not use


    NIGHTTIME 

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dosage
    • mL milliliter
    • tsp = teaspoon

    Age Dose  
    adults & children
    12 years over 
    		 4 tsp (20 mL) every 4 hours
    children 6 years to
    under 12 years
    		 2 tsp (10 mL) every 4 hours
    children under 6 years do not use

  • OTHER INFORMATION


    DAYTIME

    • each teaspoon (tsp) contains: sodium 5 mg
    • store at 20-25ºC (68-77ºF)
    • measuring cup provided

       

    NIGHTTIME


    • each teaspoon (tsp) contains: sodium 5 mg
    • store at 20-25ºC (68-77ºF) 
    • measuring cup provided
  • INACTIVE INGREDIENTS

    DAYTIME

    anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

    NIGHTTIME
    anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red  #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • PRINCIPAL DISPLAY PANEL

    DAY/NIGHT PACK

    NDC 51316-939-04

    CVS Health 

    Compare to the active Ingredients in Children's Dimetapp® Cold & Cough*

    Compare to the active Ingredients in Children's Dimetapp® Nighttime Cold & Cough*

     

    Children's Daytime Cold & Cough

     

    BROMPHENIRAMINE MALEATE
    Antihistamine

    DEXTROMETHORPHAN HBr

    Cough suppressant


    PHENYLEPHRINE HCl

    Nasal decongestant


    DM Liquid

    Relieves:

    Nasal congestion; Stuffy nose;

    Runny nose; Sneezes


    Calms allergy symptoms
    Soothes Cough

    Alcohol Free


    Grape Flavor

    Ages 6 Years & Over


    4 FL OZ (118 mL)


    Children's Nighttime Congestion & Cold 

     

    DIPHENYLHYDRAMINE HCl

    Cough suppressant; Antihistamine

     

    PHENYLEPHRINE HCl

    Nasal decongestant


    Liquid


    Relieves:

    Nasal congestion; Stuffy nose;

    Runny nose; Sneezes


    Calms allergy symptoms
    Soothes Cough


    Alcohol Free


    Grape Flavor

    Ages 6 Years & Over


    4 FL OZ (118 mL)


    577598.jpg



  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION 
    brompheniramine maleate, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-939
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-939-041 in 1 KIT; Type 0: Not a Combination Product01/31/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    CHILDRENS DAYTIME COLD AND COUGH 
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Item Code (Source)NDC:51316-916
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-916-031 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/03/2025
    Part 2 of 2
    CHILDRENS NIGHTTIME CONGESTION AND COLD 
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Item Code (Source)NDC:51316-919
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-919-031 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/03/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/31/2025
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(51316-939)
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