Indications and uses
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Ibuprofen PM
- Manufacturer
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Effective date
- 2022-10-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:50:54
Label at a glance#
ProductIbuprofen PM
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) protect from light swallow whole; do not crush, chew, or dissolve
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:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thining (antocoagulant) or steroid drug
- 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. TYhese can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- 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, 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
- 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
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
- you have symptoms of heart problem 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,
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 (1-800-222-1222)
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)
- protect from light
- swallow whole; do not crush, chew, or dissolve
Inactive ingredients
anidrisorb,FD&C blue #1, D&C red #33, gelatin, hydrolyzed gelatin, medium chain triglycerides, opacode white ink, polyethylene glycol 600, potassium hydroxide, purified water. Ingredients of opacode white ink, shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone, purified water
Questions or comments?
Call 1-888-309-9030
Principal Display Panel
Compare to the active ingredients of Advil® PM**
Ibuprofen PM Capsules
Ibuprofen 200 mg / Pain reliever (NSAID)
Diphenhydramine HCl 25 mg / Nighttime Sleep-Aid
SOFTGELS**
(**liquid filled capsules)
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM.
TAMPER-EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072
Product Packaging
Products#
Every source-derived product name is available through these pages.
- Ibuprofen PM
- IBUPROFEN, DIPHENHYDRAMINE HCL
- IBUPROFEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- D&C RED NO. 33
- GELATIN
- POLYETHYLENE GLYCOL 600
- POTASSIUM HYDROXIDE
- WATER
- SORBITAN
- SORBITOL
- MEDIUM-CHAIN TRIGLYCERIDES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55910-856 | 55910-856-40, 55910-856-20 |
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 |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | 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 |
|---|---|---|---|---|---|---|---|
| A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 |
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 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 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 |
|---|---|---|---|---|---|---|
| dfa0efe8-ca0f-4aa9-bccd-9cdac7aef39d | 8664cc8d-b56f-460d-9a52-cae6378ccaa4 | 2022-10-24 | Warnings | dfa0efe8-ca0f-4aa9-bccd-9cdac7aef39d 8664cc8d-b56f-460d-9a52-cae6378ccaa4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.