Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)

Manufacturer
Amneal Pharmaceuticals of New York LLC
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 00:06:17

Label at a glance#

ProductIbuprofen Pain Releiver/ Fever Reducer
Active ingredientIBUPROFEN
Label structure17 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

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:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever

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 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

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • 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

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor’s care for any serious condition
  • 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
  • fever gets worse or lasts more than 3 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.

KEEP OUT OF REACH OF CHILDREN

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. (1-800-222-1222)

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

SPL UNCLASSIFIED SECTION

  • read all warnings and directions before use
  • store between 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate,  Titanium Dioxide

Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Titanium Dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

SPL UNCLASSIFIED SECTION

Distributed By:

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

Rev. 10-2022-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53746-140-24

Ibuprofen Tablets USP, 200 mg

24 Tablets

Amneal Pharmaceuticals LLC

11

NDC 53746-143-24

Ibuprofen Tablets USP, 200 mg

24 Tablets

Amneal Pharmaceuticals LLC

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN16
310965ibuprofen 200 MG Oral TabletSCD16
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY16

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-140-012021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-102021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-242021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-143-012021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-143-102021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-143-242021-03-18C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-012021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-102021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-140-242021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-143-012021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-143-102021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)
53746-143-242021-01-29C16284748780-1ba0f9c33-58e9-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP Pain reliever/fever reducer (NSAID)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-140-01IbuprofenPain Releiver/ Fever Reducer100 in 1 BOTTLETABLET10016
53746-140-10IbuprofenPain Releiver/ Fever Reducer1000 in 1 BOTTLETABLET100016
53746-140-24IbuprofenPain Releiver/ Fever Reducer24 in 1 BOTTLETABLET2416
53746-143-01IbuprofenPain Releiver/ Fever Reducer100 in 1 BOTTLETABLET10016
53746-143-10IbuprofenPain Releiver/ Fever Reducer1000 in 1 BOTTLETABLET100016
53746-143-24IbuprofenPain Releiver/ Fever Reducer24 in 1 BOTTLETABLET2416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-140IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, Legacy NDC, 3 package rows20240101_ee241be0-35f8-4789-a71f-98de31d6a590.zip
53746-143IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, Legacy NDC, 3 package rows20240101_ee241be0-35f8-4789-a71f-98de31d6a590.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-140-01EA - Each53746-1409b59909e-f012-4650-b0bb-48b24756969612013-02-11
53746-140-10EA - Each53746-140ec68f427-dec6-4174-929c-cfc07f475edc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM12
IBUPROFENACTIVE MOIETYWK2XYI10QM12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK12
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A812
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G67512
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3012
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A12
POVIDONESINACTIVE INGREDIENTFZ989GH94E12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU412
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A212
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP12

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
53746-14053746-140-24, 53746-140-01, 53746-140-10
53746-14353746-143-24, 53746-143-01, 53746-143-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 104 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates

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
A071333-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-02-17

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 22:38:342026-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1784e616aacf4f…
2026-08-18 06:07:402026-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17f41ea6bd6efb…

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
Ibuprofen Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCee241be0-35f8-4789-a71f-98de31d6a5902023-12-31WarningsExact identifier
ndc (package): 53746-140-01
ndc (package): 53746-143-10
ndc (package): 53746-140-10
ndc (package): 53746-140-24
ndc (package): 53746-143-24
ndc (package): 53746-143-01
ndc (product): 53746-143
ndc (product): 53746-140
ndc11 (package): 53746014301
ndc11 (package): 53746014310
ndc11 (package): 53746014001
ndc11 (package): 53746014024
ndc11 (package): 53746014010
ndc11 (package): 53746014324
spl id: e2b9bf54-0449-4f9b-86e8-e3b292387dd5
spl set id: ee241be0-35f8-4789-a71f-98de31d6a590

Reported adverse events (FAERS/openFDA)#

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