Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 19cd2409-d56b-4319-833c-eacc7dc498c1
Route
ORAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Propylene Glycol Water Sucralose Xanthan Gum Edetate Disodium Propyl Gallate Sodium Benzoate Sodium Citrate Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-30

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCI 2.5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCI 2.5 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose
Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. 
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • mL = milliliter
age  dose 
 children 6 years to under 12 years  10 mL every 4 hours 
 children 4 years to under 6 years  5 mL every 4 hours
 children under 4 years  do not use


Do Not Use
  • 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Package Label
WALGREENS Children's Mucus Congestion & Cough Berry Flavor
Other Information
  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredients in Children's Mucinex® Congestion & Cough††

Children's

Mucus Congestion & Cough Relief

DEXTROMETHORPHAN HBr 5 mg /

COUGH SUPPRESSANT

GUAIFENESIN 100 mg /

EXPECTORANT

PHENYLEPHRINE HCI 2.5 mg /

NASAL DECONGESTANT

Alcohol Free

  • Relief from chest congestion, cough & stuffy nose
  • Breaks up mucus

AGES 4 - 11 YEARS

Berry flavor

DOSAGE CUP PROVIDED

FL OZ (mL)

††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Congestion & Cough.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product,

 do not use more than directed.

Stop Use and Ask A Doctor If
  • your child gets nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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

Guaifenesin 100 mg

Phenylephrine HCI 2.5 mg

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)
  • persistent or chronic cough such as occurs with asthma

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose
Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. 
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • mL = milliliter
age  dose 
 children 6 years to under 12 years  10 mL every 4 hours 
 children 4 years to under 6 years  5 mL every 4 hours
 children under 4 years  do not use


Do Not Use (Do not use)
  • 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Package Label
WALGREENS Children's Mucus Congestion & Cough Berry Flavor
Other Information (Other information)
  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredients in Children's Mucinex® Congestion & Cough††

Children's

Mucus Congestion & Cough Relief

DEXTROMETHORPHAN HBr 5 mg /

COUGH SUPPRESSANT

GUAIFENESIN 100 mg /

EXPECTORANT

PHENYLEPHRINE HCI 2.5 mg /

NASAL DECONGESTANT

Alcohol Free

  • Relief from chest congestion, cough & stuffy nose
  • Breaks up mucus

AGES 4 - 11 YEARS

Berry flavor

DOSAGE CUP PROVIDED

FL OZ (mL)

††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Congestion & Cough.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

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)
  • your child gets nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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

Guaifenesin 100 mg

Phenylephrine HCI 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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)