ADVIL PM - Select Consumer Group | Select Consumer Group LLC

Manufacturer
Select Consumer Group | Select Consumer Group LLC
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:36:28

Label at a glance#

ProductADVIL PM
Active ingredientDIPHENHYDRAMINE CITRATE, IBUPROFEN
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 caplets at bedtime do not take more than 2 caplets in 24 hours

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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 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 caplets at bedtime
  • do not take more than 2 caplets in 24 hours

Other ingredients

SPL UNCLASSIFIED SECTION

  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

Additional Information

SPL UNCLASSIFIED SECTION

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

For most recent product information, visit www.Advil.com.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2021 GSK or licensor Trademarks owned or licensed by GSK

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advilpm-2Advilpm-2Advilpm-5Advilpm-5AdvilPM-4AdvilPM-4Advil PM-4Advil PM-4Advil PM -1Advil PM -1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708017807GTIN-13: 0655708017807
EAN-13: 0655708017807
GTIN-12: 655708017807
UPC-A: 655708017807
GTIN storage (14 digits): 00655708017807
2501780055 - Advil PM - 1784-4.jpg
BarcodeEAN-130655708017845GTIN-13: 0655708017845
EAN-13: 0655708017845
GTIN-12: 655708017845
UPC-A: 655708017845
GTIN storage (14 digits): 00655708017845
2501784059 - Advil PM - 1784-5.jpg
BarcodeEAN-130655708117842GTIN-13: 0655708117842
EAN-13: 0655708117842
GTIN-12: 655708117842
UPC-A: 655708117842
GTIN storage (14 digits): 00655708117842
2511784055 - Advil PM - 1784-1.jpg
BarcodeEAN-130655708217849GTIN-13: 0655708217849
EAN-13: 0655708217849
GTIN-12: 655708217849
UPC-A: 655708217849
GTIN storage (14 digits): 00655708217849
2521784058 - Advil PM - 1784-2.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0164-05EA - Each0573-016429ee0873-ce1d-488b-945e-8060bb4ccb4a12012-07-24
0573-0164-08EA - Each0573-016461da8eca-12fa-4e21-ad47-a371b3e87f9912022-06-06
0573-0164-12EA - Each0573-016417b84eac-a74d-4ffe-8ac8-3de75c13d8e012019-06-19
0573-0164-14EA - Each0573-0164f1a6b8ef-c28d-4a6d-9a89-98d4e537201512019-06-19
0573-0164-20EA - Each0573-0164e0975540-d483-4aa3-9a5f-a647f2986fcc12012-07-24
0573-0164-30EA - Each0573-0164da7bb72a-9d06-4eb0-b919-d8739362742012012-07-24
0573-0164-40EA - Each0573-0164ad944255-4b0d-4ec7-9f86-47f47e6b9d9112012-07-24
0573-0164-43EA - Each0573-016440258c9f-9173-4c4c-95de-258d67f51a5f12013-08-02
0573-0164-55EA - Each0573-016488938333-f8b2-4a98-8627-645de71706b212014-02-04

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-178485237-1784-0, 85237-1784-1, 85237-1784-2, 85237-1784-4, 85237-1784-5, 85237-1784-7
0573-0164

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
N021394-001ADVIL PMDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / ORALRLD, RS2005-12-21

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 22:38:342026-08N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021394-00182636472022-05-30Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021394-00182636472022-05-30Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021394-00182636472022-05-30Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021394-00182636472022-05-30Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021394-00182636472022-05-30Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021394-00182636472022-05-30Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021394-00182636472022-05-30Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N021394-00182636472022-05-30Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021394-00182636472022-05-30Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021394-00182636472022-05-30Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021394-00182636472022-05-30Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021394-00182636472022-05-30Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021394-00182636472022-05-30Drug productea99ee380514…
2023-01-26 05:58 UTC2023-01N021394-00182636472022-05-30Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021394-00182636472022-05-30Drug product3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021394-00182636472022-05-30Drug productf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021394-00182636472022-05-30Drug producte64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021394-00182636472022-05-30Drug productcb3db0bc1861…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENSelect Consumer Group52c67ae0-707c-851b-e063-6294a90afda42026-05-27WarningsExact identifier
ndc (package): 85237-1784-1
ndc (package): 85237-1784-7
ndc (package): 85237-1784-4
ndc (package): 85237-1784-0
ndc (package): 85237-1784-2
ndc (package): 85237-1784-5
ndc (product): 85237-1784
ndc11 (package): 85237178400
ndc11 (package): 85237178402
ndc11 (package): 85237178404
ndc11 (package): 85237178405
ndc11 (package): 85237178401
ndc11 (package): 85237178407
spl id: 52c6675a-0f8f-f7bf-e063-6394a90acddc
spl set id: 52c67ae0-707c-851b-e063-6294a90afda4
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENHaleon US Holdings LLC658fc201-47c9-6a6d-8af9-6208298d43b42024-04-08WarningsExact identifier
ndc (product): 0573-0164

Reported adverse events (FAERS/openFDA)#

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