FDA.reportPublic FDA data

Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 240 mg

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2026-01-06
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 01:31:46

Label at a glance#

ProductPseudoephedrine Hydrochloride
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure13 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)                                               

Pseudoephedrine Hydrochloride USP 240 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  •   temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  •   reduces swelling of nasal passages
  •   relieves sinus pressure

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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).

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • you experience persistent abdominal pain or vomiting

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  •   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 INGREDIENT SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 5 Blister CartonPPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 5 Blister Carton

 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049670pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN1
104967024 HR pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD1
1049670pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-884-27Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, EXTENDED RELEASE11
58602-884-27Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101
58602-884-58Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51
58602-884-58Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, EXTENDED RELEASE21

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-88458602-884-58, 58602-884-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
CELLULOSE ACETATE3J2P07GVB6IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIBUTYL SEBACATE4W5IH7FLNYIACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEU72Q2I8C85IACT
HYPROMELLOSE 2208 (100000 MPA.S)VM7F0B23ZIIACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218854-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218854-001PSEUDOEPHEDRINE HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALRS2025-12-29a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC77e4132e-470e-4fb4-bc2f-df2e59061ba92026-01-06WarningsExact identifier
ndc (package): 58602-884-58
ndc (package): 58602-884-27
ndc (product): 58602-884
ndc11 (package): 58602088458
ndc11 (package): 58602088427
spl id: 77e4132e-470e-4fb4-bc2f-df2e59061ba9
spl set id: 77e4132e-470e-4fb4-bc2f-df2e59061ba9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.