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

Purpose

Cough suppressant Nasal decongestant  

Description

Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg


Medication Information

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

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
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

Description

Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

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.

Purposes

Cough suppressant

Nasal decongestant 

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
Questions Or Comments?

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

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
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
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

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.

Purposes

Cough suppressant

Nasal decongestant 

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
Questions Or Comments? (Questions or comments?)

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

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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