Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 85b87cd9-90a8-4e52-a78e-377668b868df
Route
ORAL
Published
Effective Date 2016-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Acesulfame Potassium Alcohol Benzoic Acid Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Maltitol Propylene Glycol Water Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-31

Description

Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant Nasal decongestant  


Medication Information

Purpose

Cough suppressant Nasal decongestant  

Description

Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

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

Cough suppressant

Nasal decongestant 

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
 age  dose
 children 6 to under 12 years of age  10 mL every 4 hours
 children 4 to 5 years  5 mL every 4 hours
 children under 4 years  do not use
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.
Package Label
Well at Walgreens Childrens Daytime Cold & Cough Cherry Liquid
Other Information
  • each 5 mL contains: sodium 2 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, maltitol, flavor, propylene glycol, purified water, sodium citrate

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Children's Daytime

Cold & Cough

Dextromethorphan HBr / Cough suppressant

Phenylephrine HCl / Nasal decongestant

  • Alcohol 0.14%

Cherry Flavor

FL OZ (mL)

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

When Using This Product,

do not use more than directed.

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.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma.

Structured Label Content

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

Cough suppressant

Nasal decongestant 

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
 age  dose
 children 6 to under 12 years of age  10 mL every 4 hours
 children 4 to 5 years  5 mL every 4 hours
 children under 4 years  do not use
Do Not Use (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.
Package Label
Well at Walgreens Childrens Daytime Cold & Cough Cherry Liquid
Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, maltitol, flavor, propylene glycol, purified water, sodium citrate

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Children's Daytime

Cold & Cough

Dextromethorphan HBr / Cough suppressant

Phenylephrine HCl / Nasal decongestant

  • Alcohol 0.14%

Cherry Flavor

FL OZ (mL)

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (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. (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.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma.

Advanced Ingredient Data


Raw Label Data

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