ADVIL DUAL ACTION WITH ACETAMINOPHEN - Select Consumer Group

Manufacturer
Select Consumer Group
Effective date
2026-07-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:43:15

Label at a glance#

ProductADVIL DUAL ACTION WITH ACETAMINOPHEN
Active ingredientIBUPROFEN, ACETAMINOPHEN
Label structure9 sections

Storage and handling

Other information 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)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • muscular aches
    • minor pain of arthritis

WARNINGS SECTION

Warnings

Acetaminophen liver damage warning:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Acetaminophen allergy alert:may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

SPL UNCLASSIFIED SECTION

NSAID 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.

NSAID 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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you have ever had an allergic reaction to acetaminophen or any other pain reliever
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers
  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • 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

  • 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
  • redness or swelling is present in the painful area
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed

adults and children

12 years and over

  • take 2 caplets every 8 hourswhile symptoms persist

children under 12 years

  • ask a doctor
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor

STORAGE AND HANDLING SECTION

Other information

  • 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 INGREDIENT SECTION

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1886-11886-11886-61886-6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708018866GTIN-13: 0655708018866
EAN-13: 0655708018866
GTIN-12: 655708018866
UPC-A: 655708018866
GTIN storage (14 digits): 00655708018866
2501886167 - Advil Dual Action - 1886-6.jpg
BarcodeEAN-130655708118863GTIN-13: 0655708118863
EAN-13: 0655708118863
GTIN-12: 655708118863
UPC-A: 655708118863
GTIN storage (14 digits): 00655708118863
2511886157 - Advil Dual Action - 1886-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0147-09EA - Each0573-0147594ad440-0e6d-4409-8126-29af7eeb6c6412024-12-10
0573-0147-86EA - Each0573-0147203f8a8a-d4e6-4f58-8405-8a84dc3a904012024-12-10
0573-0147-94EA - Each0573-01470600a503-4311-4e1a-9f4d-3fe895b9ae3b12021-10-08
0573-0147-95EA - Each0573-01478987ba23-fe04-4d0a-9a96-921186f6c1e912024-12-10

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-188685237-1886-0, 85237-1886-1, 85237-1886-2, 85237-1886-7, 85237-1886-4, 85237-1886-6
0573-0147

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORALRLD, RS2020-02-28

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211733-001119186932041-07-09Drug product2024-03-26

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2884e616aacf4f…
2026-08-18 06:07:402026-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211733-001ADVIL DUAL ACTION WITH ACETAMINOPHEN250MG;125MGTABLET / ORALRLD, RS2020-02-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N211733-001119186932041-07-09Drug product2024-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N211733-001119186932041-07-09Drug product2024-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211733-001119186932041-07-09Drug product2024-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211733-001119186932041-07-09Drug product2024-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N211733-001119186932041-07-09Drug product2024-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211733-001119186932041-07-09Drug product2024-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211733-001119186932041-07-09Drug product2024-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211733-001119186932041-07-09Drug product2024-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211733-001119186932041-07-09Drug product2024-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211733-001119186932041-07-09Drug product2024-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211733-001119186932041-07-09Drug product2024-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211733-001119186932041-07-09Drug product2024-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211733-001119186932041-07-09Drug product2024-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211733-001119186932041-07-09Drug product2024-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211733-001119186932041-07-09Drug product2024-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211733-001119186932041-07-09Drug product2024-03-268072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211733-001119186932041-07-09Drug product2024-03-26a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211733-001NP2023-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211733-001NP2023-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211733-001NP2023-02-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211733-001NP2023-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211733-001NP2023-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211733-001NP2023-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N211733-001NP2023-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211733-001NP2023-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211733-001NP2023-02-28c0c555d07b60…
2023-12-20 04:57 UTC2023-12N211733-001NP2023-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211733-001NP2023-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211733-001NP2023-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211733-001NP2023-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211733-001NP2023-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N211733-001NP2023-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N211733-001NP2023-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211733-001NP2023-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211733-001NP2023-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211733-001NP2023-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211733-001NP2023-02-28cb3db0bc1861…

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 DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENSelect Consumer Group55cd65fc-91bf-4979-e063-6294a90ab9b72026-07-04WarningsExact identifier
ndc (package): 85237-1886-7
ndc (package): 85237-1886-1
ndc (package): 85237-1886-6
ndc (package): 85237-1886-2
ndc (package): 85237-1886-4
ndc (package): 85237-1886-0
ndc (product): 85237-1886
ndc11 (package): 85237188606
ndc11 (package): 85237188602
ndc11 (package): 85237188604
ndc11 (package): 85237188600
ndc11 (package): 85237188607
ndc11 (package): 85237188601
spl id: 55cd6613-74f5-3d01-e063-6294a90a6cca
spl set id: 55cd65fc-91bf-4979-e063-6294a90ab9b7
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCf5ea858e-76d9-4777-b3dc-5d614f66d4852025-04-21WarningsExact identifier
ndc (product): 0573-0147

Reported adverse events (FAERS/openFDA)#

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