Ibuprofen Tablets

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2022-03-03
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:39

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure16 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 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 24 hours, unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.   see top panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

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

Purposes

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

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)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
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 24 hours, unless directed by a doctor
children under 12 years
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. 
  • see top panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call 1-855-274-4122  


Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520


Code No.: TS/DRUGS/22/2009
Made in India


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-801-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets*                   *Capsule-Shaped Tablets
AUROHEALTH
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-801-21
#Compare to the active
ingredient of MOTRIN® IB

Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets*                 *Capsule-Shaped Tablets
AUROHEALTH
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-801-07Ibuprofen1 in 1 CARTONTABLET13
58602-801-07Ibuprofen24 in 1 BOTTLETABLET243
58602-801-12Ibuprofen1 in 1 CARTONTABLET13
58602-801-12Ibuprofen40 in 1 BOTTLETABLET403
58602-801-14Ibuprofen1 in 1 CARTONTABLET13
58602-801-14Ibuprofen50 in 1 BOTTLETABLET503
58602-801-15Ibuprofen60 in 1 BOTTLETABLET603
58602-801-15Ibuprofen1 in 1 CARTONTABLET13
58602-801-19Ibuprofen90 in 1 BOTTLETABLET903
58602-801-19Ibuprofen1 in 1 CARTONTABLET13
58602-801-21Ibuprofen100 in 1 BOTTLETABLET1003
58602-801-21Ibuprofen1 in 1 CARTONTABLET13
58602-801-29Ibuprofen150 in 1 BOTTLETABLET1503
58602-801-29Ibuprofen1 in 1 CARTONTABLET13
58602-801-34Ibuprofen1 in 1 CARTONTABLET13
58602-801-34Ibuprofen200 in 1 BOTTLETABLET2003
58602-801-35Ibuprofen225 in 1 BOTTLETABLET2253
58602-801-35Ibuprofen1 in 1 CARTONTABLET13
58602-801-36Ibuprofen250 in 1 BOTTLETABLET2503
58602-801-36Ibuprofen1 in 1 CARTONTABLET13
58602-801-38Ibuprofen300 in 1 BOTTLETABLET3003
58602-801-40Ibuprofen500 in 1 BOTTLETABLET5003
58602-801-41Ibuprofen1000 in 1 BOTTLETABLET10003
58602-801-59Ibuprofen1500 in 1 BOTTLETABLET15003
58602-801-87Ibuprofen550 in 1 BOTTLETABLET5503
58602-801-88Ibuprofen750 in 1 BOTTLETABLET7503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-801IBUPROFEN TABLET [AUROHEALTH LLC]3Current NDC, Legacy NDC, 26 package rows20220310_0ade8ee2-7c74-4b05-925e-d92742fc2b90.zip

Products#

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

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

NDC Codes#

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

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 44.

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
A208865-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2017-11-08

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-083f01610625f2…
2019-09-15 20:21 UTC2019-09A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208865-001IBUPROFEN200MGTABLET / ORAL2017-11-083a93d1ddd44b…

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
IbuprofenIBUPROFENAurohealth LLC0ade8ee2-7c74-4b05-925e-d92742fc2b902022-03-03WarningsExact identifier
ndc (package): 58602-801-07
ndc (package): 58602-801-88
ndc (package): 58602-801-87
ndc (package): 58602-801-40
ndc (package): 58602-801-35
ndc (package): 58602-801-15
ndc (package): 58602-801-29
ndc (package): 58602-801-41
ndc (package): 58602-801-21
ndc (package): 58602-801-14
ndc (package): 58602-801-34
ndc (package): 58602-801-59
ndc (package): 58602-801-36
ndc (package): 58602-801-12
ndc (package): 58602-801-38
ndc (package): 58602-801-19
ndc (product): 58602-801
ndc11 (package): 58602080187
ndc11 (package): 58602080115
ndc11 (package): 58602080138
ndc11 (package): 58602080188
ndc11 (package): 58602080140
ndc11 (package): 58602080107
ndc11 (package): 58602080141
ndc11 (package): 58602080159
ndc11 (package): 58602080114
ndc11 (package): 58602080112
ndc11 (package): 58602080135
ndc11 (package): 58602080134
ndc11 (package): 58602080121
ndc11 (package): 58602080136
ndc11 (package): 58602080119
ndc11 (package): 58602080129
spl id: 19309ddd-73dc-462a-afaa-899834a2d783
spl set id: 0ade8ee2-7c74-4b05-925e-d92742fc2b90

Reported adverse events (FAERS/openFDA)#

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