Label: DIMETAPP NIGHTTIME COLD AND CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride solution

  • NDC Code(s): 80070-340-04
  • Packager: Foundation Consumer Brands
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)Purposes
    Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant
    Phenylephrine HCl, 5 mgNasal decongestant
  • Uses

    • temporarily relieves:
      • nasal congestion
      • runny nose
      • cough
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes due to hay fever
    • temporarily restores freer breathing through the nose
  • Warnings

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

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • 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

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

    When using this product

    • do not use more than directed
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, 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

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not get better 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

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosage cup provided
    • keep dosage cup with product
    • mL = milliliter
    agedose
    adults and children 12 years and over20 mL every 4 hours
    children 6 to under 12 years10 mL every 4 hours
    children under 6 yearsdo not use
  • Other information

    • each 10 mL contains: sodium 8 mg
    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • Questions or comments?

    Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Foundation Consumer Brands, LLC
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    CHILDREN'S
    Dimetapp®

    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    PHARMACIST
    RECOMMENDED

    Nighttime
    Cold &
    Congestion

    Relieves + comforts:

    ✔
    Stuffy, runny nose
    ✔
    Itchy, watery eyes
    ✔
    Sneezing
    ✔
    Cough

    6+
    YRS

    4 FL OZ
    (118 mL)

    Grape Flavor • Alcohol Free

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DIMETAPP   NIGHTTIME COLD AND CONGESTION
    diphenhydramine hydrochloride and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-340
    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)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80070-340-041 in 1 CARTON09/15/2021
    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 drugM01209/15/2021
    Labeler - Foundation Consumer Brands (117603632)
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