Ibuprofen and Diphenhydramine HCl

Manufacturer: Walgreens
Effective date: 2019-10-04
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:08:37

Label at a glance#

ProductIbuprofen and Diphenhydramine HCl

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 childlren 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 high humidity and excessive heat above 40°C (104°F) protect from light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredient (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)
*non-steroidal anti-inflammatory drug

Purpose

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:

have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed
have 3 or more alcoholic drinks every day while using this product

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

in children under 12 years of age
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
unless you have time for a full night’s sleep
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

the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have glaucoma
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have a breathing problem such as emphysema or chronic bronchitis
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
taking any other drug
taking any other antihistamines
taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
under a doctor's care for any continuing medical illness

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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- leg swelling
- slurred speech
- weakness in one part or side of body
pain gets worse or last 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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
adults and childlren 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 high humidity and excessive heat above 40°C (104°F)
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen PM

Ibuprofen 200 mg /Pain Reliever (NSAID)

Diphenhydramine HCl, 25 mg / Nighttime Sleep-Aid

SEE NEW WARNINGS

NIGHTTIME

SOFTGELS**

(**lIquid-Filled Capsules)

Compare to Advil® PM LIQUI-GELS® active ingredients≠≠

≠≠This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM LIQUI-GELS®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED: BY WALGREENS CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0665-40	EA - Each	0363-0665	868fdcdd-0e82-4360-900b-a28a40bd5c2d	1	2022-06-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Ibuprofen and Diphenhydramine HCl
IBUPROFEN, DIPHENHYDRAMINE HCL
IBUPROFEN
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0665	0363-0665-20, 0363-0665-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT

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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
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 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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`c2088c7a36db…`
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…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7ef35afc-5065-4e1b-9ed2-99e327f5b664			b8bbc3b4-cd9d-42b4-a750-66b0ee017538	2019-10-04	Warnings	Exact identifier spl id: 7ef35afc-5065-4e1b-9ed2-99e327f5b664 spl set id: b8bbc3b4-cd9d-42b4-a750-66b0ee017538

Reported adverse events (FAERS/openFDA)#

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