IBUPROFEN

Manufacturer
Strides Pharma Inc | Strides Pharma Global Pte. Ltd. | Strides Pharma Science Limited
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:43:03

Label at a glance#

ProductIBUPROFEN IMMEDIATE RELEASE
Active ingredientIBUPROFEN
Label structure13 sections

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 tablet or caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used do not exceed 6 tablets or caplets in 24 hours, unless directed by a doctor children under 12 years    •   ask a doctor              OTHER IN...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

(in each white tablet or caplet**)

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

**capsule-shaped tablets                                    

PURPOSES

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USE(S)

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 USP 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 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, 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 tablet or caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
  • do not exceed 6 tablets or caplets in 24 hours, unless directed by a doctor
children under 12 years
   •   ask a doctor
            

OTHER INFORMATION

  • store at 20-250C (68-770F)
  • do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

INACTIVE INGREDIENT (S)

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?

Call 1-855-742-7868

Manufactured by:

Strides Pharma Science Limited,

Puducherry - 605 014, India

PON/DRUGS/16134193

Distributed by:

Strides Pharma Inc

East Brunswick, NJ 08816

January 2022

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

NDC 59556-811-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug

24 Coated container label
24 Coated container label
24 s container label
24 s container label

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 · 20 matching rows.

Source Document#

Source XML · Source PDF

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
A206989-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2018-06-29

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
2026-10-15 13:18:302026-09A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29c2088c7a36db…
2026-09-14 22:38:342026-08A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-2984e616aacf4f…
2026-08-18 06:07:402026-07A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206989-001IBUPROFEN200MGTABLET / ORAL2018-06-293a93d1ddd44b…

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
be698520-4d6d-4c0b-96d9-1c668ee6576c798053dd-10f6-4c2e-8de8-1222dbd0d1692025-01-10WarningsExact identifier
spl id: be698520-4d6d-4c0b-96d9-1c668ee6576c
spl set id: 798053dd-10f6-4c2e-8de8-1222dbd0d169

Reported adverse events (FAERS/openFDA)#

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