Pseudoephedrine Hydrochloride Extended-release Tablets, Usp 240 Mg

Pseudoephedrine Hydrochloride Extended-release Tablets, Usp 240 Mg
SPL v2
SPL
SPL Set ID 1425a847-bf34-1795-e063-6294a90a85b6
Route
ORAL
Published
Effective Date 2026-02-03
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (240 mg)
Inactive Ingredients
Ferrosoferric Oxide Cellulose Acetate Silicon Dioxide Dibutyl Sebacate Glyceryl Mono- And Dicaprylocaprate Hypromellose 2208 (100000 Mpa.s) Hypromellose 2910 (3 Mpa.s) Lactose Monohydrate Microcrystalline Cellulose Polyethylene Glycol 400 Polyvinyl Alcohol, Unspecified Propylene Glycol Shellac Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: P240 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
ANDA Active Since 2026-01-30

Description

Active ingredient (in each tablet)                                                Pseudoephedrine Hydrochloride USP 240 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Active ingredient (in each tablet)                                                Pseudoephedrine Hydrochloride USP 240 mg

Uses
  •   temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  •   reduces swelling of nasal passages
  •   relieves sinus pressure
Section 50566-9
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • you experience persistent abdominal pain or vomiting
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

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.

Directions
adults and children

12 years and over

  • swallow one whole tablet with water every 24 hours
  • do not exceed one tablet in 24 hours
  • do not divide, crush, chew or dissolve the tablet
  • the tablet does not completely dissolve and may be seen in the stool (this is normal)
children under 12 years

do not use this product in children under 12 years of age

Drug Facts

Active ingredient (in each tablet)                                               

Pseudoephedrine Hydrochloride USP 240 mg

Other Information
  •   store at 20° to 25°C (68° to 77°F).
  •   do not use if the individual blister unit is open or torn
  •   see side panel for lot number and expiration date
  •   FDA approved dissolution test specifications differ from USP.
Inactive Ingredients

black iron oxide, cellulose acetate, colloidal silicon dioxide, dibutyl sebacate, glyceryl mono and dicaprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.



Questions or comments?



call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)



DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015


 

MADE IN INDIA



Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • had obstruction or narrowing of the bowel Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).
When Using This Product Do Not Exceed Recommended Dosage

Stop use and ask a doctor if

Package Label Principal Display Panel 1 X 10 Blister Carton Label

Walgreens



NEW



Compare to the active ingredient

in Sudafed® Sinus Congestion 24 Hour††



24 HOUR • NON-DROWSY



Nasal

Decongestant D



PSEUDOEPHEDRINE HYDROCHLORIDE

EXTENDED-RELEASE TABLETS, USP 240 mg /

NASAL DECONGESTANT



Maximum Strength        24 Hour

• Sinus pressure & congestion



10

TABLETS          ACTUAL SIZE




Structured Label Content

Uses
  •   temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  •   reduces swelling of nasal passages
  •   relieves sinus pressure
Section 50566-9 (50566-9)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • you experience persistent abdominal pain or vomiting
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nasal decongestant

Warnings

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.

Directions
adults and children

12 years and over

  • swallow one whole tablet with water every 24 hours
  • do not exceed one tablet in 24 hours
  • do not divide, crush, chew or dissolve the tablet
  • the tablet does not completely dissolve and may be seen in the stool (this is normal)
children under 12 years

do not use this product in children under 12 years of age

Drug Facts

Active ingredient (in each tablet)                                               

Pseudoephedrine Hydrochloride USP 240 mg

Other Information (Other information)
  •   store at 20° to 25°C (68° to 77°F).
  •   do not use if the individual blister unit is open or torn
  •   see side panel for lot number and expiration date
  •   FDA approved dissolution test specifications differ from USP.
Inactive Ingredients (Inactive ingredients)

black iron oxide, cellulose acetate, colloidal silicon dioxide, dibutyl sebacate, glyceryl mono and dicaprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.



Questions or comments?



call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)



DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015


 

MADE IN INDIA



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. (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • had obstruction or narrowing of the bowel Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).
When Using This Product Do Not Exceed Recommended Dosage (When using this product do not exceed recommended dosage)

Stop use and ask a doctor if

Package Label Principal Display Panel 1 X 10 Blister Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 10 Blister Carton Label)

Walgreens



NEW



Compare to the active ingredient

in Sudafed® Sinus Congestion 24 Hour††



24 HOUR • NON-DROWSY



Nasal

Decongestant D



PSEUDOEPHEDRINE HYDROCHLORIDE

EXTENDED-RELEASE TABLETS, USP 240 mg /

NASAL DECONGESTANT



Maximum Strength        24 Hour

• Sinus pressure & congestion



10

TABLETS          ACTUAL SIZE




Advanced Ingredient Data


Raw Label Data

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