Ibuprofen Tablets USP 200 mg (Brown)

Manufacturer
Granules India Limited
Effective date
2023-12-14
Label type
BULK INGREDIENT
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:18:15

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure18 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 a caplet every 4 to 6 hours while symptoms persist ■ if pain or fever dose not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours , unless directed by a doctor childer under 12 years ■ ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Ibuprofen 200 mg (NSAID)*

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug

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

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 A DOCTOR

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

OTHER INFORMATION

■ store between 20-25ºC (68-77ºF)

■ do not use if foil inner seal is broken or missing

■ see end panel for lot number and expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maize starch, maltodextrin, pregelatinized starch, povidone k30, sodium starch glycolate, stearicacid, sodium carboxymellose, triacetin, titanium dioxide

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST

SPL UNCLASSIFIED SECTION

M.L. 37/RR/AR/2003/F/R
Manufactured By:
Granules India Limited
2nd Floor 3rd Black, My Home hub
Madhapur, Hyderabad – 500 081, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ibu-200mg-round-80kg.jpgibu-200mg-round-80kg.jpgibu-roundibu-roundibu-capletibu-caplet

365-68365-68365-68-shipper365-68-shipper366-68366-68366-68-shipper366-68-shipper

Products#

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NDC Codes#

Ingredients#

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

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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 43.

Orange Book products#

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Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

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
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2026-08-18 06:07:402026-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b00525d2431f…
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2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10f41ea6bd6efb…

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
IbuprofenIBUPROFENGranules India Limitedfd01353d-1d1d-42b5-9a03-575052189bf52024-08-13WarningsExact identifier
ndc (product): 62207-365
ndc (product): 62207-366

Reported adverse events (FAERS/openFDA)#

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