FDA.reportPublic FDA data

Leader 44-438

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-06-18 05:10:09

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: muscular aches backache toothache menstrual cramps headache the common cold minor pain of arthritis temporarily reduces fever

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor 

Storage and handling

store between 20º-25ºC (68º-77ºF) avoid excessive heat 40ºC (104ºF) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each white tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • toothache
    • menstrual cramps
    • headache
    • the common cold
    • minor pain of arthritis
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • rash
  • facial swelling
  • asthma (wheezing)
  • hives
  • skin reddening
  • shock
  • 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
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

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

  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers 

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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • store between 20º-25ºC (68º-77ºF)
  • avoid excessive heat 40ºC (104ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0291-1

Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 TABLETS

ACTUAL SIZE

100% Money Back Guarantee

Leader 44-438
Leader 44-438

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295131963GTIN-13: 0096295131963
EAN-13: 0096295131963
GTIN-12: 096295131963
UPC-A: 096295131963
GTIN storage (14 digits): 00096295131963		leader-44-438-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0291-1EA - Each70000-02912d8520ac-6b4c-49e1-901e-23fa95d67ead12019-06-19

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-029170000-0291-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-06-12full-release2026-06-01 01:02:58

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
A075139-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

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 22:38:342026-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01f41ea6bd6efb…

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
IbuprofenIBUPROFENCardinal Health 110, LLC. DBA Leadera41a0bc2-ef7a-44cd-a42e-aefab41323cc2026-06-15WarningsExact identifier
ndc (package): 70000-0291-1
ndc (product): 70000-0291
ndc11 (package): 70000029101
spl id: a67d0d00-851e-43af-b69e-0afcc08e626c
spl set id: a41a0bc2-ef7a-44cd-a42e-aefab41323cc

Reported adverse events (FAERS/openFDA)#

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