Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough Kit
FDA Label NDC 69536-365

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 Healthcare for the product Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough (NDC 69536-365). 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 ®
Cold and Cough

Drug Facts

Dimetapp ®
Nighttime Cold and Cough

Drug Facts

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

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.
    • to sedate a child or to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

When Using This Product

  • 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
    • 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

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 6 mg
  • store at 20-25°C (68-77°F)
    • 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, 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, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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