FDA.reportPublic FDA data

Cardinal Health Dual Action Pain Reliever Drug Facts

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-29 01:01:55

Label at a glance#

ProductLeader Dual Action Pain Reliever
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure9 sections

Indications and uses

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

Dosage and administration

• do not take more than directed Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist Children under 12 years: ask a doctor

Storage and handling

• 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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Acetaminophen liver damage warning:

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

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.

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:

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: 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

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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed

    Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist

    Children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING 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

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADERTM

Dual Action Pain Reliever

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

8 HOUR RELIEF

CONTAINS 2 MEDICINES

Acetaminophen + Ibuprofen

COMPARE TO ADVIL® DUAL ACTION active ingredients

36 CAPLETS**

**Capsule-Shaped Tablets

ACTUAL SIZE

100% Money Back Guarantee

leader-dual-action-pain-reliever-carton-image.jpg
leader-dual-action-pain-reliever-carton-image.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-073770000-0737-2, 70000-0737-1

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
ACETAMINOPHEN362O9ITL9DACTIB
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-09-30full-release2026-06-01 01:15:33

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
A214836-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28

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 22:38:342026-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a50c72e98297…

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
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
ndc (package): 70000-0737-1
ndc (package): 70000-0737-2
ndc (product): 70000-0737
ndc11 (package): 70000073701
ndc11 (package): 70000073702
spl id: c84b338a-505b-4233-8da9-f6fd312ccdfb
spl set id: 2bb1f616-48af-4fe1-9aa9-32fcb2dba50c

Reported adverse events (FAERS/openFDA)#

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