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 Extended-Release Tablets, USP
- Manufacturer
- The Kroger Company | Ohm Laboratories Inc. | Ohm Laboratories Inc
- Effective date
- 2026-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:03:09
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?
1-800-632-6900
SPL UNCLASSIFIED SECTION
PROUDLY DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton
NDC 30142-967-20
Kroger ®
Pseudoephedrine Hydrochloride 120 mg
12 Hour Extended-Release Tablets, USP
20 COATED CAPLETS* 120 mg EACH
*capsule-shaped tablets
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0041260013140 | GTIN-13: 0041260013140 EAN-13: 0041260013140 GTIN-12: 041260013140 UPC-A: 041260013140 GTIN storage (14 digits): 00041260013140 | Kroger Pseudo 120 mg 20ct Carton.jpg |
| Data code | ITF | 05272623 | Kroger Pseudo 120 mg 20ct 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 |
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 |
|---|---|
| 30142-967 | 30142-967-20 |
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 |
|---|---|---|---|
| 3 | 2026-09-16 | daily-update | 2026-09-19 01:01:03 |
| 2 | 2021-04-13 | full-release | 2026-05-31 23:39:40 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| 77ce98b8-4c34-41de-8d2b-45137f48a692 | 00a8327b-41f0-4498-ad13-331256b539f9 | 2021-04-13 | Warnings | 00a8327b-41f0-4498-ad13-331256b539f9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.