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
  • 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 August 12, 2021

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

  • 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)

    Nighttime
    Cold &
    Congestion

    Relieves Nasal Symptoms

    Stuffy Nose
    Runny Nose
    Sneezing

    Plus Other Symptoms

    Itchy, Watery Eyes
    Cough

    For Ages
    6 Yrs.
    & Over

    4 FL OZ (118 mL)

    alcohol-free • grape flavor

    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 FINALpart34109/15/2021
    Labeler - Foundation Consumer Brands (117603632)