FDA.reportPublic FDA data

Sudafed Sinus Congestion 12 Hour

Manufacturer
REMEDYREPACK INC.
Effective date
2022-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:10:45

Label at a glance#

ProductSudafed Sinus Congestion 12 Hour
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 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 torn or broken 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#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - DO NOT USE 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

OTC - WHEN USING SECTION

When using this product 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

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 torn or broken
  • 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

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Sudafed Sinus Congestion 12 Hour

GENERIC: Pseudoephedrine Hydrochloride

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2654-0

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 19 mm

IMPRINT: SU12

PACKAGING: 10 in 1 BLISTER PACK

OUTER PACKAGING: 2 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Pseudoephedrine Hydrochloride 120mg in 1

INACTIVE INGREDIENT(S):

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

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2654-02022-01-31C16284748780-1d6a99b39-96cf-a426-e053-dadaa90af4c2Sudafed Sinus Congestion 12 Hour
70518-2654-02022-01-28C16284748780-1d6a99b39-96cf-a426-e053-dadaa90af4c2Sudafed Sinus Congestion 12 Hour

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-242-01EA - Each50580-2427f942de9-00b8-4305-94c4-53aea9f24f8e12020-04-20
50580-242-03EA - Each50580-242604ab0c6-ab3d-4a65-93bb-92039ba7482512026-01-08

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
70518-265470518-2654-0
50580-242

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
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

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
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
Sudafed Sinus Congestion 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCd600b5d5-7d95-4ad6-a95b-6d73502743d72024-11-08WarningsExact identifier
ndc (product): 50580-242
07d6aa1d-16fa-fb9b-e063-6394a90a79d7abafe8b6-2877-49a1-80e4-3077093a1eaa2023-10-16WarningsExact identifier
spl set id: abafe8b6-2877-49a1-80e4-3077093a1eaa

Reported adverse events (FAERS/openFDA)#

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