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

  • NDC Code(s): 11673-058-04, 11673-059-08, 11673-613-04
  • Packager: TARGET Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 15, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients for Nighttime (in each 10 mL)

    Diphenhydramine HCI 12.5 mg

    Phenylephrine HCI 5 mg 

  • Active ingredients for Daytime (in each 10 mL)

    Brompheniramine Maleate 2 mg

    Dextromethorphan HBr 10mg 

    Phenylephrine HCl 5 mg

  • Purpose for Nighttime

    Antihistamine / Cough suppressant

    Nasal Decongestant

  • Purpose for Daytime

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses

    Nighttime

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

    Daytime

    • temporaily relieves cough due to minor throat and bronchial irritation occuring 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)
      • runny nose
      • itchy, watery eyes
      • sneezing
      • itching of the nose or throat
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    Nighttime

    • 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
    • with any other product containing diphenhydramine, even one used on skin.

    Daytime

    • to sedate a child or to make sleepy
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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

    Nighttime

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that last as occurs with smoking,asthma, chronic bronchitis or emphysema

    Daytime

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

    Ask a doctor or pharmacist before use if you are

    Nighttime

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

    Daytime

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

    When using these products

    Nighttime

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitablity may occur, especially in children

    Daytime

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedative and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    Nighttime

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with a 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

    Daytime

    • 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,

    Nighttime

    ask a health professional before use.

    Daytime

    ask a health professional before use

    Keep out of reach of children.

    Nighttime

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    Daytime

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Nighttime

    • do not take more than 6 doses in any 24 hours period
    • do not exceed recommended dosage
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • mL = mililiter
    AgeDose 
     adults and children 12 years and over 20 mL every 4 hours
     childen 6 to under 12 years 10 mL every 4 hours
     children under 6 years do not use

    Daytime

    • do not take more than 6 doses in any 24 hours period
    • measure only with dosing cup provided. Do not use any other dosing dosing device.
    • keep dosing cup with product
    • mL = mililiter
    Age Dose 
     adults and children12 years and over 20 mL every 4 hours
     children 6 to under 11 years 10 mL every 4 hours
     Children under 6 years do not use

  • Other information

    Nighttime

    • each 10 mL contains: sodium 6 mg
    • store between 20-25ºC (68-77ºF)
    • do not refrigerate
    • protect from light

    Daytime

    • each 10 mL contains: 5 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    Nighttime

    acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C Blue #1, FD&C red #40, Flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

    Daytime

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

  • Questions or comments?

    Nighttime

    Call 1-800-910-6874

    Daytime

    Call 1-800-910-6874

  • Principal Display Panel

    Compare to active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**

    Children's night time

    Cold & Congestion

    Diphenhydramine HCI 12.5 mg (Antihistamine-Cough Suppressant)

    Phenylephrine HCI 5 mg (Nasal Decongestant)

    stuffy nose

    runny nose

    sneezing

    itchy,watery eyes

    cough

    GRAPE FLAVOR

    DOSING CUP INCLUDED

    AGES 6 + YEARS

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    **This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Nighttime Cold & Congestion.

    DAYTIME

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

    children's day time

    Cold + Cough

    Brompheniramine Maleate 2 mg (Antihistamine)

    Dextromethorphan HBr 10 mg (Cough Suppressant)

    Phenylephrine HCI 5 mg (Nasal Decongestant)

    cough

    itchy, watery eyes

    runny nose

    sneezing

    stuffy nose

    itchy of the nose or throat

    alcohol free

    GRAPE FLAVOR

    DOSING CUP INCLUDED

    AGES 6 + YEARS

    GRAPE FLAVOR

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Children's Dimetapp® Cold & Cough.

    Distributed by Target Corporation

    Minneapolis, MN 55403

    ©2015 Target Brands, Inc.

  • Product Label

    Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg, Brompheniramine HBr 10 mg, Dextromethorphan HBr10 mg, Phenylephrine HCI 5 mg

    TARGET Children's Nighttime Cold and Congestion Children's Daytime Cold and Cough

  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION  CHILDRENS
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-059
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-059-081 in 1 KIT; Type 0: Not a Combination Product07/31/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    NIGHT TIME COLD AND CONGESTION  CHILDRENS
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Item Code (Source)NDC:11673-058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALTITOL (UNII: D65DG142WK)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-058-04118 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 FINALpart34107/31/2015
    Part 2 of 2
    DAYTIME COLD AND COUGH  CHILDRENS
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Item Code (Source)NDC:11673-613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-613-04118 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 FINALpart34107/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/31/2015
    Labeler - TARGET Corporation (006961700)