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
Sudafed 12 Hour
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2019-03-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:26:17
Label at a glance#
ProductSudafed 12 Hour
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections
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
store at 59° to 77°F in a dry place. Protect from light do not use if carton is opened or if blister unit is broken see side panel for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl 120 mg
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Warnings
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
- 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
- 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
| adults and children 12 years and over |
|
| children under 12 years | do not use this product in children under 12 years of age |
Other information
- store at 59° to 77°F in a dry place. Protect from light
- do not use if carton is opened or if blister unit is broken
- see side panel for lot number and expiration date
Inactive ingredients
candelilla wax, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide
Questions or comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
HOW SUPPLIED
Product: 50090-1106
NDC: 50090-1106-0 10 TABLET, FILM COATED, EXTENDED RELEASE in a BLISTER PACK / 1 in a CARTON
Pseudoephedrine hydrochloride
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1106-0 | EA - Each | 50090-1106 | abcecf81-100a-44f0-b7fb-c2173ea02059 | 1 | 2018-11-06 |
| 50580-670-10 | EA - Each | 50580-670 | e1e7de32-09d8-420b-b9bd-2710401a1d40 | 1 | 2012-07-24 |
| 50580-670-20 | EA - Each | 50580-670 | c0d26ab6-3bf3-49e1-9bde-94e7db65ab03 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Sudafed 12 Hour
- Pseudoephedrine hydrochloride
- PSEUDOEPHEDRINE
- candelilla wax
- FD&C blue no. 1
- aluminum oxide
- HYPROMELLOSE, UNSPECIFIED
- magnesium stearate
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- propylene glycol
- shellac
- talc
- titanium dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-1106 | 50090-1106-0 |
| 50580-670 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073585-001 | SUDAFED 12 HOUR | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 1991-10-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073585-001 | SUDAFED 12 HOUR | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1991-10-31 | 3a93d1ddd44b… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5b288d47-9a57-46dd-a667-b31702079613 | e75cc740-df45-411c-ab80-af8f43474bd3 | 2019-03-15 | Warnings | 5b288d47-9a57-46dd-a667-b31702079613 e75cc740-df45-411c-ab80-af8f43474bd3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.