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 capsules at bedtime ■ do not take more than 2 capsules in 24 hours
■ each capsule contains: potassium 20 mg ■ read all warnings and directions before use. Keep carton. ■ store at 20° to 25°C (68° to 77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to
200 mg ibuprofen (NSAID) *
(present as the free acid and potassium salt)
*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 ■ skin reddening ■ rash ■ 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
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.
■ 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, asthma, or had a stroke
■ 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
■ 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
■ 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
■ you have symptoms of heart problems or stroke:
■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling
■ 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery 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 capsules at bedtime
■ do not take more than 2 capsules in 24 hours
■ each capsule contains: potassium 20 mg
■ read all warnings and directions before use. Keep carton.
■ store at 20° to 25°C (68° to 77°F)
■ avoid excessive heat above 40°C (104°F)
■ protect from light
gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
call toll-free 1-888-235-2466
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
†This product is not manufactured or distributed by the owners of Advil® PM LIQUI-GELS®.
DISTRIBUTED BY:
WHOLE FOODS MARKET| 550 BOWIE STRRET, AUSTIN, TX 78703
©2020 WHOLE FOODS MARKET IP, INC. I
www.wholefoodsmarket.com
L0001211 R0126
Lot No:
Exp. Date:
365
WHOLE FOODS
MARKET
NDC 42681-0061-1
buprofen PM
Ibuprofen &
Diphenhydramine HCI
Solubilized Ibuprofen, 200mg/
Diphenhydramine HCI, 25mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid
**Compare to the Active Ingredients in Advil® PM LIQUI-GELS®
40
CAPSULES
Softgels*
*Liquid-Filled Capsules
| 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 |
|---|---|---|---|---|---|---|
| 42681-0061-1 | Ibuprofen PM | 40 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 40 | 1 | |
| 42681-0061-1 | Ibuprofen PM | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42681-0061 | 42681-0061-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 |
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 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090397-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2010-11-22 | 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 |
|---|---|---|---|---|---|---|
| Ibuprofen PM | IBUPROFEN AND DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 4db58605-9cc7-e57e-e063-6294a90ab800 | 2026-03-23 | Warnings | 42681-0061-1 42681-0061 42681006101 4db585fe-bff2-f8a1-e063-6294a90acb3a 4db58605-9cc7-e57e-e063-6294a90ab800 |
Adverse event summaries are temporarily unavailable. Other product information remains available.