IBUPROFEN TABLETS USP 200 mg

Manufacturer
One2Zee Limited Liability Company | Strides Pharma Science Limited
Effective date
2019-09-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:12:51

Label at a glance#

ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure11 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 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 20-25°C (68-77°F) ■ tamper evident: do not use if imprinted safety seal under cap is broken or missing;                                   do not use if seal is open or missing in bulk pack.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 200 mg (NSAID)*

____________________________________

* nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever / fever reducer

INDICATIONS AND USAGE

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
  • rash
  • blisters
  • shock
  • skin reddening
  • asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a non-steroidal anti-inflammatory drug (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

Do not use

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

Ask a doctor before use if

  • 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, or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • 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

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

■ 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

■ 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 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.

OTC - 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 (1-800-222-1222) right away.

DOSAGE AND ADMINISTRATION

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 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

STORAGE AND HANDLING SECTION

■ Store between 20-25°C (68-77°F)

■ tamper evident: do not use if imprinted safety seal under cap is broken or missing;

                                  do not use if seal is open or missing in bulk pack.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS

OTC - QUESTIONS SECTION

Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM

SPL UNCLASSIFIED

SPL UNCLASSIFIED SECTION

Manufactured by:

Strides Pharma Science Limited

Puducherry - 605014, India

See New Warnings Information

Ibuprofen Tablets USP 200 mg

Pain Reliever / Fever Reducer (NSAID)

- 30000 coated tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-09555629-095-01

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
A079129-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-03-28

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 13:18:302026-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c2088c7a36db…
2026-09-14 22:38:342026-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283a93d1ddd44b…

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f9b136cf-cddf-4831-bf8a-bf7e4a3b20a7aafdafad-2587-4d62-9705-c68beab87ba62019-09-11WarningsExact identifier
spl id: f9b136cf-cddf-4831-bf8a-bf7e4a3b20a7
spl set id: aafdafad-2587-4d62-9705-c68beab87ba6

Reported adverse events (FAERS/openFDA)#

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