Indications and uses
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Ibuprofen and Diphenhydramine HCl
- Manufacturer
- EQUATE (Wal-Mart Stores, Inc.)
- Effective date
- 2021-10-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:31:14
Label at a glance#
ProductIbuprofen and Diphenhydramine HCl
Active ingredientIBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
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) do not chew or crush prior to swallowing protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each capsule)
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
Nighttime sleep-aid
Pain Reliever
Uses
- for relief of occasional sleeplessness when associated with minor aches and pains
- helps you fall asleep and stay asleep
Warnings
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
Do not use
- 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
- 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, or asthma
- 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
- 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
- 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
Stop use and ask a doctor if
- 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
- 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,
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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
- 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)
- do not chew or crush prior to swallowing
- protect from light
Inactive ingredients
FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Questions or comments?
Call 1-888-287-1915
Principal Display Panel
Compare to Advil® PM Liqui-Gels® Active Ingredients**
Ibuprofen PM Softgels
Ibuprofen 200 mg
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid
NIGHTTIME
SOFTGELS**
(**liquid filled capsules)
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DO NOT USE IF TAMPER-EVIDENT: SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
DISTRIBUTED: BY Wal-Mart Stores, Inc.,
Bentonville, AR 72716
Product Packaging
Products#
Every source-derived product name is available through these pages.
- 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 |
|---|---|
| 49035-065 | 49035-065-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| 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#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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.
| 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 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1b5dbbc9-023b-481e-be91-954e7e375cb5 | 17e9f4aa-404e-45a1-adc9-e775c4ec36ec | 2021-10-20 | Warnings | 1b5dbbc9-023b-481e-be91-954e7e375cb5 17e9f4aa-404e-45a1-adc9-e775c4ec36ec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.