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  5. Label Information: Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough

FDA Label for Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - KIT CARTON

Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Foundation Consumer Healthcare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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