Pseudoephedrine Hydrochloride Extended-release Tablets, Usp 240 Mg

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 2025-12-29

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:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

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 2 X 5 Blister Carton Label

AUROHEALTH

NDC 58602-884-58

^#Compare to the active

ingredient in Sudafed^® Sinus Congestion 24 Hour.

Pseudoephedrine Hydrochloride

Extended-Release Tablets, USP 240 mg

Nasal Decongestant

MAXIMUM STRENGTH

24

HOUR

• SINUS PRESSURE + CONGESTION

• NON-DROWSY

Actual Size

2 x 5 tablets per blister card

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:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

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 2 X 5 Blister Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 5 Blister Carton Label)

AUROHEALTH

NDC 58602-884-58

^#Compare to the active

ingredient in Sudafed^® Sinus Congestion 24 Hour.

Pseudoephedrine Hydrochloride

Extended-Release Tablets, USP 240 mg

Nasal Decongestant

MAXIMUM STRENGTH

24

HOUR

• SINUS PRESSURE + CONGESTION

• NON-DROWSY

Actual Size

2 x 5 tablets per blister card

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "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", "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": " 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: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009", "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 - 2 x 5 Blister Carton Label": "AUROHEALTH NDC 58602-884-58 # Compare to the active ingredient in Sudafed ® Sinus Congestion 24 Hour. Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 240 mg Nasal Decongestant MAXIMUM STRENGTH 24 HOUR • SINUS PRESSURE + CONGESTION • NON-DROWSY Actual Size 2 x 5 tablets per blister card "}