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
Pseudoephedrine hydrochloride 120 mg 12 Hour Extended-Release Tablets, USP
- Manufacturer
- STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.
- Effective date
- 2026-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:03:13
Label at a glance#
ProductPseudoephedrine hydrochloride
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 TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Pseudoephedrine HCl, USP 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
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive ingredients
castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide
Questions?
Call 833-358-6431M - F, 9AM - 7PM EST
SPL UNCLASSIFIED SECTION
Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141
PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton
NDC 70677-1019-1
COMPARE TO SUDAFED
®
SINUS CONGESTION 12 HOUR ACTIVE INGREDIENT*
Foster & Thrive ®
MAXIMUM STRENGTH
Nasal Decongestant
Pseudoephedrine Hydrochloride 120 mg
Extended-Release Tablets, USP
Long-Acting Nasal Decongestant
Non-Drowsy
12 hour
- Sinus Pressure + Congestion
ACTUAL SIZE
10 Coated Capsule-Shaped Tablets 120 mg Each
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0010939955371 | GTIN-13: 0010939955371 EAN-13: 0010939955371 GTIN-12: 010939955371 UPC-A: 010939955371 GTIN storage (14 digits): 00010939955371 | High Res Foster and Thrive Pseu 12hr Tab 10ct Carton.jpg |
| Data code | ITF | 05269951 | High Res Foster and Thrive Pseu 12hr Tab 10ct Carton.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-1019-1 | EA - Each | 70677-1019 | 9c16ed02-80c3-41d8-b7ff-be3f73400bfd | 1 | 2024-01-04 |
| 70677-1019-2 | EA - Each | 70677-1019 | 771a37df-376d-47e5-9d8c-bf2b52730d37 | 1 | 2026-05-22 |
Products#
Every source-derived product name is available through these pages.
- Pseudoephedrine hydrochloride
- PSEUDOEPHEDRINE
- CASTOR OIL
- SILICON DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70677-1019 | 70677-1019-1, 70677-1019-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| CASTOR OIL | D5340Y2I9G | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-05-06 | full-release | 2026-06-01 01:56:30 |
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 |
|---|---|---|---|---|---|---|---|
| A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 512ccc87-b95a-7e0e-e063-6294a90a2716 | 3bf95c58-4fd9-4caa-a54f-2e61a5eacae8 | 2026-05-06 | Warnings | 3bf95c58-4fd9-4caa-a54f-2e61a5eacae8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.