Dimetapp Elixir
FDA Label NDC 80070-310

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Brands for the product Dimetapp (NDC 80070-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Dimetapp®
Nighttime Cold and Congestion

Drug Facts

Dimetapp®
Cold and Cough

Drug Facts

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

Otc - Purpose

Active ingredients (in each 10 mL)Purposes
Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant
Phenylephrine HCl, 5 mgNasal decongestant
Active ingredients (in each 10 mL)Purposes
Brompheniramine maleate, 2 mgAntihistamine
Dextromethorphan HBr, 10 mgCough 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
      • 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

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
    • 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.

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
    • 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 such 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
    • 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
    • do not use more than directed
    • may cause marked drowsiness
    • avoid alcoholic beverages
    • 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.
    • 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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
    • 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
    • each 10 mL contains: sodium 6 mg
    • store at 20-25°C (68-77°F)

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

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, 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

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

Principal Display Panel - Kit Carton

Day & Night

Children's
Dimetapp®

BROMPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Cold &
Cough

Relieves Nasal Symptoms

  • ✔Stuffy Nose
  • ✔Runny Nose
  • ✔Sneezing

    • Plus Other Symptoms

    • ✔Itchy, Watery Eyes
    • ✔Cough

      • For Ages
      6 Yrs.
      & Over

      1 BOTTLE 4 FL OZ (118 mL)
      alcohol-free • grape flavor

      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

          1 BOTTLE 4 FL OZ (118 mL)
          alcohol-free • grape flavor

          8 FL OZ (236 mL) TOTAL

          Principal Display Panel (Kit Carton)

          Principal Display Panel (Kit Carton)

* Please review the disclaimer below.