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
Diphenhydramine citrate 38 mg
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain reliever
• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives • facial swelling • asthma (wheezing) • shock • rash • skin reddening • blisters 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 • are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• unless you have time for a full night’s sleep
• in children under 12 years of age
• right before or after heart surgery
• with any other product containing diphenhydramine, even one used on skin
• if you have sleeplessness without pain
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
• you are taking a diuretic
• you have a breathing problem such as emphysema or chronic bronchitis
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland
you are
• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor’s care for any continuing medical illness
• taking any other antihistamines
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug
• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
• you experience any of the following signs of stomach bleeding:
• feel faint • vomit blood • have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear
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 right away.
• 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)
calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate,
hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Call toll free 1-800-88-ADVIL
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67751-147-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-d953-0266-e053-dadaa90a7c1a | Advil PM |
| 67751-147-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-d953-0266-e053-dadaa90a7c1a | Advil PM |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67751-147-01 | Advil PM | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 67751-147-01 | Advil PM | 2 in 1 POUCH | TABLET, COATED | 2 | 3 | |
| 67751-147-02 | Advil PM | 4 in 1 POUCH | TABLET, COATED | 4 | 3 | |
| 67751-147-02 | Advil PM | 2 in 1 CARTON | TABLET, COATED | 2 | 3 | |
| 67751-147-06 | Advil PM | 2 in 1 POUCH | TABLET, COATED | 2 | 3 | |
| 67751-147-06 | Advil PM | 3 in 1 CARTON | TABLET, COATED | 3 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0164-05 | EA - Each | 0573-0164 | 29ee0873-ce1d-488b-945e-8060bb4ccb4a | 1 | 2012-07-24 |
| 0573-0164-08 | EA - Each | 0573-0164 | 61da8eca-12fa-4e21-ad47-a371b3e87f99 | 1 | 2022-06-06 |
| 0573-0164-12 | EA - Each | 0573-0164 | 17b84eac-a74d-4ffe-8ac8-3de75c13d8e0 | 1 | 2019-06-19 |
| 0573-0164-14 | EA - Each | 0573-0164 | f1a6b8ef-c28d-4a6d-9a89-98d4e5372015 | 1 | 2019-06-19 |
| 0573-0164-20 | EA - Each | 0573-0164 | e0975540-d483-4aa3-9a5f-a647f2986fcc | 1 | 2012-07-24 |
| 0573-0164-30 | EA - Each | 0573-0164 | da7bb72a-9d06-4eb0-b919-d87393627420 | 1 | 2012-07-24 |
| 0573-0164-40 | EA - Each | 0573-0164 | ad944255-4b0d-4ec7-9f86-47f47e6b9d91 | 1 | 2012-07-24 |
| 0573-0164-43 | EA - Each | 0573-0164 | 40258c9f-9173-4c4c-95de-258d67f51a5f | 1 | 2013-08-02 |
| 0573-0164-55 | EA - Each | 0573-0164 | 88938333-f8b2-4a98-8627-645de71706b2 | 1 | 2014-02-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67751-147 | 67751-147-01, 67751-147-02, 67751-147-06 |
| 0573-0164 |
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, IBUPROFEN | Navajo Manufacturing Company Inc. | a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7 | 2026-04-08 | Warnings | 67751-147-06 67751-147-02 67751-147-01 67751-147 67751014702 67751014706 67751014701 4efb3fed-e69e-91c7-e063-6294a90aafdd a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7 |
| ADVIL PM | DIPHENHYDRAMINE CITRATE AND IBUPROFEN | Haleon US Holdings LLC | 658fc201-47c9-6a6d-8af9-6208298d43b4 | 2024-04-08 | Warnings | 0573-0164 |
Adverse event summaries are temporarily unavailable. Other product information remains available.