Indications and uses
temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
● do not take more than directed ● the smallest effective dose should be used ● adults and children 12 years of age and over: ● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. ● do not use more than 6 capsules in any 24-hour period unless directed by a doctor ● children under 12 years of age: do not use Other...
Active ingredients (in each liquid-filled capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
Pseudoephedrine Hydrochloride USP 30 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
temporarily relieves these symptoms associated with the common cold or flu:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
● do not take more than directed
● the smallest effective dose should be used
● adults and children 12 years of age and over:
● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
● do not use more than 6 capsules in any 24-hour period unless directed by a doctor
● children under 12 years of age: do not use
Other information
Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution.
Questions or comments? call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code:TS/DRUGS/22/2009
GOOD
NEIGHBOR
PHARMACY®
*Compare to the Advil® Cold & Sinus
active ingredients
NDC 46122-609-58
Non-Drowsy
COLD & SINUS RELIEF
Ibuprofen and Pseudoephedrine HCl Capsules
200 mg/30 mg
Pain Reliever/Fever Reducer (NSAID)/Nasal Decongestant
40 Liquid-Filled Capsules (4 X 10 capsules per blister card)
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46122-609-58 | Ibuprofen and Pseudoephedrine HCl | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 3 | |
| 46122-609-58 | Ibuprofen and Pseudoephedrine HCl | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-609-58 | EA - Each | 46122-609 | 76a3b536-a0f9-4d83-98df-fb404d01be57 | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 46122-609 | 46122-609-58 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 |
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 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209235-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE / ORAL | 2017-12-01 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Ibuprofen and Pseudoephedrine HCl | IBUPROFEN AND PSEUDOEPHEDRINE HCL | Amerisource Bergen | 8d397f4f-ac5e-426d-a26b-ee064b6e5028 | 2022-11-04 | Warnings | 46122-609-58 46122-609 46122060958 7569aff6-da0d-46b9-b7c4-bf2766827013 8d397f4f-ac5e-426d-a26b-ee064b6e5028 |
Adverse event summaries are temporarily unavailable. Other product information remains available.