Walgreens 44-056

Walgreens 44-056
SPL v4
SPL
SPL Set ID 8b5d391b-6c23-44c3-81d0-c08822bf6d01
Route
ORAL
Published
Effective Date 2025-05-10
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 Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-12

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 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 HCl 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
    • stuffy nose
    • nasal congestion due to a cold
    • the intensity of coughing
    • the impulse to cough to help the child get to sleep
Directions
  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • dose as follows or as directed by a doctor
Age Dose
children 6 to under 12 years 10 mL every 4 hours
children 4 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 giving this product.

Other Information
  • each 5 mL contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 0363-1056-88

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredients in

Children’s Mucinex® Cough & Congestion††

Children’s

Mucus

Cough &

Congestion

Relief

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

ORAL SOLUTION

• Relieves

chest congestion,

cough & stuffy nose

• Breaks up

mucus

AGES

4-11

YEARS

Berry

flavor

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

††This product is not manufactured or distributed by

RB Health (US) LLC, owner of the registered

trademark Children’s Mucinex® Cough & Congestion.

50844      ORG02230568

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2023 Walgreen Co.

Walgreens 44-056
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough persists more than 7 days, tends to recur, or is accompanied by 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 right away.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

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

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
    • stuffy nose
    • nasal congestion due to a cold
    • the intensity of coughing
    • the impulse to cough to help the child get to sleep
Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • dose as follows or as directed by a doctor
Age Dose
children 6 to under 12 years 10 mL every 4 hours
children 4 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 giving this product.

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 0363-1056-88

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredients in

Children’s Mucinex® Cough & Congestion††

Children’s

Mucus

Cough &

Congestion

Relief

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

ORAL SOLUTION

• Relieves

chest congestion,

cough & stuffy nose

• Breaks up

mucus

AGES

4-11

YEARS

Berry

flavor

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

††This product is not manufactured or distributed by

RB Health (US) LLC, owner of the registered

trademark Children’s Mucinex® Cough & Congestion.

50844      ORG02230568

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2023 Walgreen Co.

Walgreens 44-056
When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough persists more than 7 days, tends to recur, or is accompanied by 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 right away.

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

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

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

Advanced Ingredient Data


Raw Label Data

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