Walgreens 44-542

Walgreens 44-542
SPL v18
SPL
SPL Set ID cb1c1922-5dc6-520d-e77e-e951726d9701
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;542 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-04-15 Until 2020-04-07

Description

Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Expectorant Nasal decongestant


Medication Information

Purpose

Expectorant

Nasal decongestant

Description

Guaifenesin 400 mg Phenylephrine HCl 10 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure
Directions
  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use
Do Not Use

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Walgreens

  WALGREENS

PHARMACIST RECOMMENDED

NDC 0363-0542-01

Immediate Release

SINUS CONGESTION

Mucus

Relief PE

GUAIFENESIN 400 mg / EXPECTORANT

PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT

• Clears nasal & sinus congestion

• Thins & loosens mucus

30

TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Our pharmacists recommend the Walgreens brand

50844      ORG011854201

ACTUAL SIZE - CONTAINS ONE BOTTLE

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015


100% SATISFACTION GUARANTEED

walgreens.com  ©2021 Walgreen Co.

Walgreens 44-542
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by 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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
Active Ingredients (in Each Immediate Release Tablet)

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure
Purpose

Expectorant

Nasal decongestant

Directions
  • take with a full glass of water
  • adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use
Do Not Use (Do not use)

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

Walgreens

  WALGREENS

PHARMACIST RECOMMENDED

NDC 0363-0542-01

Immediate Release

SINUS CONGESTION

Mucus

Relief PE

GUAIFENESIN 400 mg / EXPECTORANT

PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT

• Clears nasal & sinus congestion

• Thins & loosens mucus

30

TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Our pharmacists recommend the Walgreens brand

50844      ORG011854201

ACTUAL SIZE - CONTAINS ONE BOTTLE

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015


100% SATISFACTION GUARANTEED

walgreens.com  ©2021 Walgreen Co.

Walgreens 44-542
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 improve within 7 days or are accompanied by 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
Active Ingredients (in Each Immediate Release Tablet) (Active ingredients (in each immediate-release tablet))

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)