Ibuprofen Tablets, USP (NSAID)Pain Reliever/ Fever Reducer DRUG FACTS

Manufacturer
Apotheca Inc.
Effective date
2010-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:23:40

Label at a glance#

ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure13 sections

Dosage and administration

d o not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in a 24-hour period, unless directed by a physician take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain or 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.

Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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

DO NOT USE

OTC - DO NOT USE SECTION

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

ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic
  • reached age 60 or older

Ask a doctor before use if you are

  • taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor's care for any serious condition
  • taking any other drug
  • consuming 3 or more alcohol drinks per day

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs
  • long term continuous use ay increase the risk of heart attack or stroke

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • 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 during the last 3 months of 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 1-800-362-0101 (Arizona only) immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take longer than 10 days, unless directed by a doctor (see Warnings)


Adults and children 12 years and older
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in a 24-hour period, unless directed by a physician
  • take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use
  • consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years
  • not for use

OTHER INFORMATION

INACTIVE INGREDIENT SECTION

Other information
  • store at 15 – 30°C (59-86°F).
Inactive ingredients

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

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 12634-860-01

IBUPROFEN

MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION

Pain Reliever
Fever Reducer

RejuviLife®

100 CAPLETS

200 MG

image of labelimage of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN3
310965ibuprofen 200 MG Oral TabletSCD3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY3

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-860-01IBUPROFEN100 in 1 BOTTLE, PLASTICTABLET1003
12634-860-10IBUPROFEN1000 in 1 BOTTLE, PLASTICTABLET10003
12634-860-24IBUPROFEN24 in 1 BOTTLE, PLASTICTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-860IBUPROFEN TABLET [APOTHECA INC.]3Legacy NDC, 3 package rows20100224_a6e57acd-b02a-472e-9cc6-8d4aea246164.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM3
IBUPROFENACTIVE MOIETYWK2XYI10QM3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WO3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
POVIDONEINACTIVE INGREDIENTFZ989GH94E3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12634-86012634-860-24, 12634-860-01, 12634-860-10
53746-142

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form

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 · 2 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…

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
A072199-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1988-05-23

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 22:38:342026-08A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-2384e616aacf4f…
2026-08-18 06:07:402026-07A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-233f01610625f2…
2019-09-15 20:21 UTC2019-09A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072199-001IBUPROFEN200MGTABLET / ORAL1988-05-23f41ea6bd6efb…

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
Ibuprofen (NSAID) Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCa8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad02023-12-31WarningsExact identifier
ndc (product): 53746-142
6e315790-ef94-4772-8e76-2565f8b097d4a6e57acd-b02a-472e-9cc6-8d4aea2461642010-02-19WarningsExact identifier
spl id: 6e315790-ef94-4772-8e76-2565f8b097d4
spl set id: a6e57acd-b02a-472e-9cc6-8d4aea246164

Reported adverse events (FAERS/openFDA)#

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