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Childrens Daytime Cold and Cough

Medically reviewed on September 4, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: CVS Pharmacy, Inc.
NDC Code: 59779-890

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 Facts

Active ingredients (in each 5 mL, 1 teaspoonful)

Dextromethorphan HBr, USP 5 mg
Phenylephrine HCl, USP 2.5 mg

Purposes

Cough suppressant
Nasal decongestant

Uses
  • temporarily relieves
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

  • in a child under 4 years of age
  • in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma

When using this product
  • do not exceed recommended dosage

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor
  • use enclosed dosing cup only. Keep for use with  this product only. Do not use any other dosing device.
  • mL= milliliter
Age
Dose
children under 4 years of age
do not use
children 4  to under 6 years of age
5 mL (1 teaspoonful)
children 6 to under 12 years of age
10 mL (2 teaspoonfuls)

Other information
  • store at controlled room temperature 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C Red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or Comments?

1-855-274-4122

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in USA
V-34202

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

CVS Health
NDC 59779-890-24

Children's
Cold &
Cough


Each 5 mL (1 tsp) dose of oral solution
contains:

DEXTROMETHORPHAN HBr, USP - 5 mg
Cough suppressant
PHENYLEPHRINE HCl, USP - 2.5 mg
Nasal decongestant

Relieves:

  • Cough
  • Stuffy nose

Alcohol free

For Ages

4 to 12 Years

Cherry Flavor Liquid

Dosage cup included

4 FL OZ (118 mL)

CHILDRENS DAYTIME COLD AND COUGH 
dextromethorphan hbr, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-890
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
CHERRY 
CLOVE 
EDETATE DISODIUM 
FD&C RED NO. 40 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
XANTHAN GUM 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY (Prosweet and Clove) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-890-241 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/19/2015
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(59779-890)

 
CVS Pharmacy, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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