Ibuprofen Tablets, USP 200 mg

Manufacturer
Granules India Limited | GRANULES LIFE SCIENCES PRIVATE LIMITED
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
weekly-update
Hydrated at
2026-07-17 21:42:21

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 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT (in each tablet/caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID) *

nonsteroidal anti-inflammatory drug

PURPOSE

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

SPL UNCLASSIFIED SECTION

Other Information

  • store at 20-25°C (68-77°F)[See USP Controlled Room Temperature]
  • avoid high humidity and excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, 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

Manufactured By:
Granules India Limited
Hyderabad – 500 043, India
MADE IN INDIA

M.L.No: 37/RR/AP/2003/F/R

Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC# 62207-366-46

See New Warnings Information


ibu-366-250ct-carton.jpgibu-366-250ct-carton.jpg

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

250 Coated Caplets †

†Capsule-Shaped Tablets

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-366-47

Do not use if the foil inner seal is broken or missing
See New Warnings Information

ibu-366-500ct-label.jpgibu-366-500ct-label.jpg

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

500 Coated Caplets†

†Capsule-Shaped Tablets

Important: Read all product information before using.


NDC# 62207-396-46

See New Warnings Information


ibu-396-250ct-carton.jpgibu-396-250ct-carton.jpgIBUPROFEN TABLETS USP, 200 mg


Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

250 Coated Caplets†

†Capsule-Shaped Tablets

Important: Read all product information before using.



NDC# 62207-396-46

Do not use if the foil inner seal is broken or missing

See New Warnings Information
ibu-396-250ct-label.jpgibu-396-250ct-label.jpg

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

500 Coated Caplets†

†Capsule-Shaped Tablets

Important: Read all product information before using.

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM11
IBUPROFENACTIVE MOIETYWK2XYI10QM11
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS31111
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083G11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G67511
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712K11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X11
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM6211
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D11
POVIDONE K30INACTIVE INGREDIENTU725QWY32X11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU411
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A211
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP11
TRIACETININACTIVE INGREDIENTXHX3C3X67311

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
182023-01-30full-release2026-05-31 23:53:37

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 8 · 468 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET / ORAL11 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KTABLET / ORAL942 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET / ORAL11 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATELX22YL083GTABLET / ORAL11 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route+dosage form
36 equally ranked IID candidates

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
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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10c2088c7a36db…
2026-09-14 22:38:342026-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1084e616aacf4f…
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…
2019-07-19 19:46 UTC2019-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a72a2bbeb626…
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…
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2023-05-13 08:27 UTC2023-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10053a50430f4f…
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2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103a93d1ddd44b…

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
IbuprofenIBUPROFENGranules India Limitedfd01353d-1d1d-42b5-9a03-575052189bf52024-08-13WarningsExact identifier
ndc (package): 62207-396-43
ndc (package): 62207-366-46
ndc (package): 62207-365-43
ndc (package): 62207-396-48
ndc (package): 62207-366-42
ndc (package): 62207-366-41
ndc (package): 62207-395-42
ndc (package): 62207-395-46
ndc (package): 62207-395-43
ndc (package): 62207-365-47
ndc (package): 62207-396-42
ndc (package): 62207-366-48
ndc (package): 62207-365-49
ndc (package): 62207-395-41
ndc (package): 62207-396-51
ndc (package): 62207-366-51
ndc (package): 62207-396-49
ndc (package): 62207-366-47
ndc (package): 62207-365-51
ndc (package): 62207-365-42
ndc (package): 62207-365-48
ndc (package): 62207-395-47
ndc (package): 62207-366-49
ndc (package): 62207-396-41
ndc (package): 62207-396-46
ndc (package): 62207-365-41
ndc (package): 62207-395-49
ndc (package): 62207-395-48
ndc (package): 62207-366-43
ndc (package): 62207-365-46
ndc (package): 62207-395-51
ndc (package): 62207-396-47
ndc (product): 62207-396
ndc (product): 62207-365
ndc (product): 62207-395
ndc (product): 62207-366
ndc11 (package): 62207036641
ndc11 (package): 62207036647
ndc11 (package): 62207036651
ndc11 (package): 62207039549
ndc11 (package): 62207039547
ndc11 (package): 62207036547
ndc11 (package): 62207039546
ndc11 (package): 62207036541
ndc11 (package): 62207036643
ndc11 (package): 62207036649
ndc11 (package): 62207036548
ndc11 (package): 62207036546
ndc11 (package): 62207039649
ndc11 (package): 62207039642
ndc11 (package): 62207039647
ndc11 (package): 62207039648
ndc11 (package): 62207039651
ndc11 (package): 62207036549
ndc11 (package): 62207039643
ndc11 (package): 62207036543
ndc11 (package): 62207039551
ndc11 (package): 62207036646
ndc11 (package): 62207036551
ndc11 (package): 62207036648
ndc11 (package): 62207039541
ndc11 (package): 62207039543
ndc11 (package): 62207036642
ndc11 (package): 62207039542
ndc11 (package): 62207039646
ndc11 (package): 62207039641
ndc11 (package): 62207036542
ndc11 (package): 62207039548
spl id: 1f8c5711-4342-d41b-e063-6394a90acb7a
spl set id: fd01353d-1d1d-42b5-9a03-575052189bf5

Reported adverse events (FAERS/openFDA)#

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