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
• store at 20 - 25° C (68 - 77° F). Avoid excessive heat above 40° C (104° F). • read all warnings and directions before use. Keep carton.
Drug Facts
temporarily relieves these symptoms associated with the common cold or flu:
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
If pregnant or breast-feeding, 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.
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)
acacia, calcium carbonate, carnauba wax, confectioner's sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
call 1-800-406-7984
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
LEADER™
NDC 70000-0602-1
Non-Drowsy
Cold & Sinus
Ibuprofen, USP 200 mg | Pseudoephedrine HCl, USP 30 mg
Pain Reliever / Fever Reducer (NSAID)* | Nasal Decongestant
*nonsteroidal anti-inflammatory drug
Relieves:
Sinus Pressure
Nasal Congestion
Fever
40 COATED CAPLETS**
(**Oval-Shaped Tablets)
COMPARE TO
ADVIL®
COLD & SINUS
active ingredients†
100% Money Back Guarantee
SEE NEW WARNINGS INFORMATION

| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0602 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 110, LLC DBA LEADER] | 2 | Legacy NDC | 20220601_2cccc119-8eea-4280-9ad9-ec29caf26940.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0602-1 | EA - Each | 70000-0602 | 9b06d9fb-2224-418d-9db2-58c4e11cab25 | 1 | 2022-11-07 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0602 | 70000-0602-1 |
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 |
|---|---|---|---|---|---|---|---|
| A074567-001 | IBUPROHM COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | TABLET / ORAL | 2001-04-17 |
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 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074567-001 | IBUPROHM COLD AND SINUS | 200MG;30MG | TABLET / ORAL | 2001-04-17 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 51236687-64be-46af-e063-6394a90a2d58 | 2cccc119-8eea-4280-9ad9-ec29caf26940 | 2026-05-06 | Warnings | 2cccc119-8eea-4280-9ad9-ec29caf26940 |
Adverse event summaries are temporarily unavailable. Other product information remains available.