Walgreens 44-057

Walgreens 44-057
SPL v4
SPL
SPL Set ID 666e90ee-0b5b-4b9b-a12b-00f33732634f
Route
ORAL
Published
Effective Date 2025-06-10
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 2024-06-02

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

Walgreens

Compare to the active ingredients

in Mucinex® Children’s

Multi-Symptom Cold††

• WALGREENS •

PHARMACIST RECOMMENDED†

MULTI-SYMPTOM

Children’s

Cold

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

ORAL SOLUTION

Alcohol Free

• Relief from: stuffy nose,

  cough & chest congestion

• Breaks up mucus

AGES

4-11

YEARS

4 FL OZ (118 mL)

Berry

flavor

†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 Mucinex® Children’s Multi-Symptom Cold.

50844 ORG022305736

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Walgreens 44-057
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 (Principal display panel)

Walgreens

Compare to the active ingredients

in Mucinex® Children’s

Multi-Symptom Cold††

• WALGREENS •

PHARMACIST RECOMMENDED†

MULTI-SYMPTOM

Children’s

Cold

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

ORAL SOLUTION

Alcohol Free

• Relief from: stuffy nose,

  cough & chest congestion

• Breaks up mucus

AGES

4-11

YEARS

4 FL OZ (118 mL)

Berry

flavor

†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 Mucinex® Children’s Multi-Symptom Cold.

50844 ORG022305736

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Walgreens 44-057
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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