FDA.reportPublic FDA data

nasal decongestant

Manufacturer
Rebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp.
Effective date
2012-12-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:03

Label at a glance#

Productnasal decongestant
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 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 45 mg store at 20° - 25°C (68° - 77°F) in a dry place protect from light do not use if blister unit is broken or torn see carton end panel for lot number and expiration date this product meets the requirements of USP Drug Release Test 3

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 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

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

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

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

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 45 mg
  • store at 20° - 25°C (68° - 77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Sudafed® 12 Hour Caplets active ingredient

Nasal Decongestant

MAXIMUM STRENGTH

NON-DROWSY

SINUS

pseudoephedrine hydrochloride extended release tablets, 120 mg

Long-Acting Nasal Decongestant

12-Hour

Sinus pressure

Congestion

Pseudoephedrine HCl

120 mg each

*(Capsule-shaped Tablets)

Nasal Decongestant 120mgNasal Decongestant 120mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN1
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD1
1049154pseudoephedrine HCl 120 MG 12 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-359-102019-09-24C16284748780-19350213a-3dbe-c013-e053-90daa90a1393Nasal Decongestant Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-359-10nasal decongestant1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE11
42254-359-10nasal decongestant10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-359NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130329_83ae6177-afbb-477f-a5ff-64d48960ffef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-359-10EA - Each42254-3593ada416a-46b9-4355-bbbd-a7e968d6f1c412013-04-01
24385-054-52EA - Each24385-054e043072c-5879-47c8-bdee-4d6614955ec412012-07-24
24385-054-61EA - Each24385-05488934df1-02e3-4e45-a093-585a7e94133112024-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42254-35942254-359-10
24385-054

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii+route+dosage form
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii+route+dosage form
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED, EXTENDED RELEASE / ORAL258.45 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii+route+dosage form

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
A075153-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26

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 22:38:342026-08A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2684e616aacf4f…
2026-08-18 06:07:402026-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good neighbor pharmacy nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergend84a0c76-ad50-4616-9252-84ca25a19ca02024-05-30WarningsExact identifier
ndc (product): 24385-054
83ae6177-afbb-477f-a5ff-64d48960ffef83ae6177-afbb-477f-a5ff-64d48960ffef2012-12-25WarningsExact identifier
spl id: 83ae6177-afbb-477f-a5ff-64d48960ffef
spl set id: 83ae6177-afbb-477f-a5ff-64d48960ffef

Reported adverse events (FAERS/openFDA)#

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