FDA.reportPublic FDA data

Pseudoephedrine HCl Extended-Release Tablets USP 120 mg

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2022-11-03
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:20

Label at a glance#

ProductPseudoephedrine HCl
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 temporarily relieves sinus congestion and pressure

Dosage and administration

adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

Storage and handling

Each tablet contains: calcium 36 mg store at 20° to 25°C (68° to 77°F). Protect from light. do not use if the individual blister unit is open or torn see side panel for lot number and expiration date Meets USP dissolution test 4

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl USP 120 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
  • temporarily relieves sinus congestion and pressure

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  •  nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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
  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 years
do not use this product in children under 12 years of age

Other information

STORAGE AND HANDLING SECTION

  • Each tablet contains: calcium 36 mg
  • store at 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if the individual blister unit is open or torn
  • see side panel for lot number and expiration date
  • Meets USP dissolution test 4

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
Compare to the active ingredient in
Sudafed® 12 Hour** 
NDC 58602-804-67
MAXIMUM STRENGTH
Long-Acting Nasal Decongestant
Pseudoephedrine HCl
Extended-Release Tablets USP 120 mg

•  SINUS PRESSURE
•  CONGESTION
•  NON-DROWSY
12 HOUR
20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release TabletsPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN3
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD3
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
58602-804-67Pseudoephedrine HCl2 in 1 CARTONTABLET, EXTENDED RELEASE23
58602-804-67Pseudoephedrine HCl10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE103
58602-804-83Pseudoephedrine HCl10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE103
58602-804-83Pseudoephedrine HCl1 in 1 CARTONTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-804PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [AUROHEALTH LLC]3Current NDC, Legacy NDC, 4 package rows20221104_1056d9da-8a3f-4b7a-878e-7f8d45d298cd.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-80458602-804-83, 58602-804-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)UKE75GEA7FIACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT
HYPROMELLOSE 2208 (4000 MPA.S)39J80LT57TIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
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
A209008-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-093f01610625f2…
2019-09-15 20:21 UTC2019-09A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209008-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL2017-06-09f41ea6bd6efb…

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 HClPSEUDOEPHEDRINE HCLAurohealth LLC1056d9da-8a3f-4b7a-878e-7f8d45d298cd2022-11-03WarningsExact identifier
ndc (package): 58602-804-67
ndc (package): 58602-804-83
ndc (product): 58602-804
ndc11 (package): 58602080467
ndc11 (package): 58602080483
spl id: 5f73d533-1e3b-4e36-8bea-6076b9d0a9b5
spl set id: 1056d9da-8a3f-4b7a-878e-7f8d45d298cd

Reported adverse events (FAERS/openFDA)#

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