Whole foods-Ibuprofen PM

Manufacturer
Whole Foods Market, INC. | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:35

Label at a glance#

ProductIbuprofen PM
Active ingredientIBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

■ for relief of occasional sleeplessness when associated with minor aches and pains ■ helps you fall asleep and stay asleep

Dosage and administration

■ 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

Storage and handling

■ 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

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 25 mg

Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID) *

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Nighttime sleep-aid

Pain reliever

Uses

INDICATIONS & USAGE SECTION

■ for relief of occasional sleeplessness when associated with minor aches and pains

■ helps you fall asleep and stay asleep

Warnings

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

■ 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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ 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

When using this product

OTC - WHEN USING SECTION

■ drowsiness will occur

■ avoid alcoholic drinks

■ do not drive a motor vehicle or operate machinery

■ take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

STORAGE AND HANDLING SECTION

■ 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

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:

40's count carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
901814ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
901814diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral CapsuleSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42681-0061-1Ibuprofen PM40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED401
42681-0061-1Ibuprofen PM1 in 1 CARTONCAPSULE, LIQUID FILLED11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42681-006142681-0061-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22

Observed Orange Book product history#

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-2284e616aacf4f…
2026-08-18 06:07:402026-07A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-223f01610625f2…
2019-09-15 20:21 UTC2019-09A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22f41ea6bd6efb…

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE HCLWhole Foods Market, INC.4db58605-9cc7-e57e-e063-6294a90ab8002026-03-23WarningsExact identifier
ndc (package): 42681-0061-1
ndc (product): 42681-0061
ndc11 (package): 42681006101
spl id: 4db585fe-bff2-f8a1-e063-6294a90acb3a
spl set id: 4db58605-9cc7-e57e-e063-6294a90ab800

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.