Indications and uses
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use Other information store at 20° to 25°C (68° to 77°F)....
Active ingredients (in each caplet)
Ibuprofen USP 200 mg (NSAID)*
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 at 20 weeks or later in 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.
Other information
colloidal silicon dioxide, corn starch, croscarmellose sodium, glyceryl monocaprylocaprate type 1, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyvinyl alcohol-part. hydrolyzed, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
Questions or comments? call 1-855-274-4122
(Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
AUROHEALTH
NDC 58602-839-13
#Compare to the active
ingredients of Advil® Cold &Sinus
Non-Drowsy
COLD & SINUS RELIEF
Ibuprofen and Pseudoephedrine
Hydrochloride Tablets USP 200 mg/30 mg
Ibuprofen USP 200 mg - Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine Hydrochloride USP 30 mg - Nasal Decongestant
32 Coated Caplets†
†Oval-Shaped tablets
| 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 |
|---|---|---|---|---|---|---|
| 58602-839-13 | Ibuprofen and Pseudoephedrine Hydrochloride | 8 in 1 BLISTER PACK | TABLET, COATED | 8 | 3 | |
| 58602-839-13 | Ibuprofen and Pseudoephedrine Hydrochloride | 4 in 1 CARTON | TABLET, COATED | 4 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-839 | 58602-839-13 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 |
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 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | 053a50430f4f… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213565-001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2023-03-10 | a50c72e98297… |
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 Hydrochloride | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Aurohealth LLC | c01116d3-32f8-41f0-8e31-c4142265ef56 | 2024-10-24 | Warnings | 58602-839-13 58602-839 58602083913 8c55a203-6e1b-4f5b-9788-cde24942b6df c01116d3-32f8-41f0-8e31-c4142265ef56 |
Adverse event summaries are temporarily unavailable. Other product information remains available.