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  5. Label Information: Daytime Cold And Cough Nighttime Cold And Congestion

FDA Label for Daytime Cold And Cough Nighttime Cold And Congestion

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S) FOR DAYTIME (IN EACH 5 ML)
    2. ACTIVE INGREDIENT(S) FOR NIGHTTIME (IN EACH 5 ML)
    3. PURPOSE FOR DAYTIME
    4. PURPOSE FOR NIGHTTIME
    5. USE(S)
    6. WARNINGS
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK DOCTOR IF
    12. IF PREGNANT OR BREAST-FEEDING
    13. KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. PRINCIPAL DISPLAY PANEL

Daytime Cold And Cough Nighttime Cold And Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Cvs. 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.

Active Ingredient(S) For Daytime (In Each 5 Ml)



Brompheniramine Maleate 1 mg 

Dextromethorphan HBr 5 mg 

Phenylephrine HCI 2.5 mg 


Active Ingredient(S) For Nighttime (In Each 5 Ml)



Diphenhydramine HCI 6.25 mg

Phenylephrine HCI 2.5 mg 


Purpose For Daytime



Antihistamine

Cough suppressant

Nasal decongestant


Purpose For Nighttime



Antihistamine / Cough suppressant

Nasal Decongestant


Use(S)




DAYTIME

  • temporarily relieves cough due to minor
    bronchial irritation as may occur with a cold, and
    nasal congestion due to the common cold, hay
    fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay
    fever (allergic rhinitis): • sneezing • itching of the
    nose or throat • runny nose • itchy, watery eyes
  • temporarily restores freer breathing through the nose

    • NIGHTTIME


    • tempuradly relieves these symptoms occuring with
      a cold, hay fever or other upper respiratory allergies:
      • sneezing. itching of the nose or throat. runny nose
      • itchy, watery eyes. cough. nasal congestion

Warnings



.


Do Not Use



Daytime

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.

      • Nighttime

      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 nut 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




DAYTIME

  • heart disease 
  • glaucoma 
  • diabetes 
  • thyroid disease 
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs wilt too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

    •  
    NIGHTTIME


    • heart disease 
    • glaucoma 
    • diabetes
    • thyroid disease 
    • high blood pressure 
    • difficulty in urination due to an enlarged prostate gland 
    • 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



DAYTIME

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

    •  

    NIGHTTIME

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

When Using This Product



DAYTIME 

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

    •  NIGHTTIME

    • do not take more than directed
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

Stop Use And Ask Doctor If



  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve 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




DAYTIME

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon

    • Age Dose  
    adults & children 12 years over 
    		 4 tsp (20 mL) every 4 hours
    children 6 years to under 12 years
    		 2 tsp (10 mL) every 4 hours
    children under 6 years do not use


    NIGHTTIME 

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dosage
    • mL milliliter
    • tsp = teaspoon

      • Age Dose  
      adults & children
      12 years over 
      		 4 tsp (20 mL) every 4 hours
      children 6 years to
      under 12 years
      		 2 tsp (10 mL) every 4 hours
      children under 6 years do not use


Other Information




DAYTIME

  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25°C (68-77°F)
  • measuring cup provided

     

    • NIGHTTIME


    • each teaspoon (tsp) contains: sodium 5 mg
    • store at 20-25°C (68-77°F) 
    • measuring cup provided

Inactive Ingredients



DAYTIME

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

NIGHTTIME
anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red  #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose


Principal Display Panel



DAY/NIGHT PACK

NDC 51316-939-04

CVS Health 

Compare to the active Ingredients in Children's Dimetapp® Cold & Cough*

Compare to the active Ingredients in Children's Dimetapp® Nighttime Cold & Cough*

 

Children's Daytime Cold & Cough

 

BROMPHENIRAMINE MALEATE
Antihistamine

DEXTROMETHORPHAN HBr

Cough suppressant


PHENYLEPHRINE HCl

Nasal decongestant


DM Liquid

Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes


Calms allergy symptoms
Soothes Cough

Alcohol Free


Grape Flavor

Ages 6 Years & Over


4 FL OZ (118 mL)


Children's Nighttime Congestion & Cold 

 

DIPHENYLHYDRAMINE HCl

Cough suppressant; Antihistamine

 

PHENYLEPHRINE HCl

Nasal decongestant


Liquid


Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes


Calms allergy symptoms
Soothes Cough


Alcohol Free


Grape Flavor

Ages 6 Years & Over


4 FL OZ (118 mL)


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* Please review the disclaimer below.