FDA.reportPublic FDA data

Ibuprofen PM

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2024-03-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:07:42

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 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 excessive heat above 40ºC (104ºF) protect from light Organic impurities Test is pending USP Dissolution Test is pending swallow whole; do not crush, chew, or dissolve

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride USP 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:

  • 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

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 reliever or fever reducer
  • 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 decease 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
    • 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,

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 (1-800-222-1222) right away.

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 excessive heat above 40ºC (104ºF)
  • protect from light
  • Organic impurities Test is pending
  • USP Dissolution Test is pending
  • swallow whole; do not crush, chew, or dissolve

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, gelatin, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No. 1, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

PACKAGE LABEL.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 f seal under bottle cap mprinted with "SEALED for YOUR ROTECTION"  IS broken or missing.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL HEALTH Ibuprofen PM
DOLLAR GENERAL HEALTH Ibuprofen PM

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-12555910-125-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14c2088c7a36db…
2026-09-14 22:38:342026-08A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-143a93d1ddd44b…

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
66bb1de6-c370-4b08-9a26-eb821e96d35c7abbf66e-0a69-428a-ab13-efaacc3ae1652024-03-18WarningsExact identifier
spl id: 66bb1de6-c370-4b08-9a26-eb821e96d35c
spl set id: 7abbf66e-0a69-428a-ab13-efaacc3ae165

Reported adverse events (FAERS/openFDA)#

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