Indications and uses
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours
read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Drug Facts
Diphenhydramine citrate 38 mg
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain reliever
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
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.
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding,
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL
Advil PM
Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever
(NSAID)/
Nighttime Sleep-Aid
2 Coated Caplets*
* Capsule-Shaped Tablets
Advil PM
Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever
(NSAID)/
Nighttime Sleep-Aid
4 Coated Caplets*
* Capsule-Shaped Tablets
Advil PM
Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever
(NSAID)/
Nighttime Sleep-Aid
6 Coated Caplets*
* Capsule-Shaped Tablets
Advil PM
Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever
(NSAID)/
Nighttime Sleep-Aid
Coated Caplets*
* Capsule-Shaped Tablets
See full Drug Facts information
on the side and back of this dispenser
30 PACKETS OF 2 COATED CAPLETS*
*Capsule-Shaped Tablets
Advil PM
Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever
(NSAID)/
Nighttime Sleep-Aid
4 Coated Caplets*
* Capsule-Shaped Tablets
CVP
HEALTH
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 29485-6533-4 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 POUCH | TABLET, COATED | 2 | 5 | |
| 29485-6533-4 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 CARTON | TABLET, COATED | 2 | 5 | |
| 29485-6644-2 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 1 in 1 BLISTER PACK | TABLET, COATED | 1 | 5 | |
| 29485-6644-2 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 POUCH | TABLET, COATED | 2 | 5 | |
| 29485-7008-3 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 POUCH | TABLET, COATED | 2 | 5 | |
| 29485-7008-3 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 30 in 1 BOX | TABLET, COATED | 30 | 5 | |
| 29485-7088-4 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 POUCH | TABLET, COATED | 2 | 5 | |
| 29485-7088-4 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 BLISTER PACK | TABLET, COATED | 2 | 5 | |
| 29485-7937-6 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 3 in 1 BLISTER PACK | TABLET, COATED | 3 | 5 | |
| 29485-7937-6 | ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | 2 in 1 POUCH | TABLET, COATED | 2 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 29485-6533 | ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC] | 5 | Current NDC, 2 package rows | 20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip |
| 29485-6644 | ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC] | 5 | Legacy NDC, 2 package rows | 20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip |
| 29485-7008 | ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip |
| 29485-7088 | ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC] | 5 | Legacy NDC, 2 package rows | 20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip |
| 29485-7937 | ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC] | 5 | Legacy NDC, 2 package rows | 20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 29485-7088 | 29485-7088-4 |
| 29485-7937 | 29485-7937-6 |
| 29485-7008 | 29485-7008-3 |
| 29485-6644 | 29485-6644-2 |
| 29485-6533 | 29485-6533-4 |
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 |
|---|---|---|---|---|---|---|---|
| N021394-001 | ADVIL PM | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 |
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 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021394-001 | ADVIL PM | 38MG;200MG | TABLET / ORAL | RLD, RS | 2005-12-21 | f41ea6bd6efb… |
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021394-001 | 8263647 | 2022-05-30 | Drug product | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021394-001 | 8263647 | 2022-05-30 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021394-001 | 8263647 | 2022-05-30 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021394-001 | 8263647 | 2022-05-30 | Drug product | ea99ee380514… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021394-001 | 8263647 | 2022-05-30 | Drug product | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021394-001 | 8263647 | 2022-05-30 | Drug product | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021394-001 | 8263647 | 2022-05-30 | Drug product | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021394-001 | 8263647 | 2022-05-30 | Drug product | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated | ADVIL PM | Lil Drug Store Products, Inc | d1138e15-8ae4-7b49-e053-2995a90a9607 | 2024-12-30 | Warnings | 29485-6644-2 29485-6533-4 29485-7008-3 29485-7937-6 29485-7088-4 29485-6644 29485-7937 29485-7088 29485-7008 29485-6533 29485793706 29485708804 29485700803 29485664402 29485653304 2a83226d-0fe9-8955-e063-6394a90a5bfc d1138e15-8ae4-7b49-e053-2995a90a9607 |
Adverse event summaries are temporarily unavailable. Other product information remains available.