Ibuprofen Capsules (liquid filled, 200 mg)

Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:29:55

Label at a glance#

ProductIbuprofen Pain Reliever/Fever Reducer
Active ingredientIBUPROFEN
Label structure16 sections

Indications and uses

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Dosage and administration

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

OTC - PURPOSE

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • 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.

OTC - DO NOT USE

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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

OTC - ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

OTC - WHEN USING

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE

OTC - STOP USE SECTION

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
  • 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

OTC - PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20º to 25ºC (68º to 77ºF)
  • avoid excessive heat above 40ºC (104ºF)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

OTC – QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

Read and keep carton for complete warnings and information.

Do not use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Distributed by: 

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

Rev. 06-2022-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65162-356-02

Ibuprofen Capsules, 200 mg

20 Capsules

Amneal Pharmaceuticals LLC

11



22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310964ibuprofen 200 MG Oral CapsulePSN11
310964ibuprofen 200 MG Oral CapsuleSCD11

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
65162-356-02IbuprofenPain Reliever/Fever Reducer1 in 1 CARTONCAPSULE, LIQUID FILLED111
65162-356-02IbuprofenPain Reliever/Fever Reducer20 in 1 BOTTLECAPSULE, LIQUID FILLED2011
65162-356-11IbuprofenPain Reliever/Fever Reducer1000 in 1 BOTTLECAPSULE, LIQUID FILLED100011
65162-356-50IbuprofenPain Reliever/Fever Reducer500 in 1 BOTTLECAPSULE, LIQUID FILLED50011
65162-356-69IbuprofenPain Reliever/Fever Reducer80 in 1 BOTTLECAPSULE, LIQUID FILLED8011
65162-356-69IbuprofenPain Reliever/Fever Reducer1 in 1 CARTONCAPSULE, LIQUID FILLED111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-356IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC]11Current NDC, Legacy NDC, 6 package rows20241027_877440fc-3afb-4123-a2e6-5cb48c74413c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
GELATININACTIVE INGREDIENT2G86QN327L2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T2
SORBITOLINACTIVE INGREDIENT506T60A25R2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65162-35665162-356-02, 65162-356-69, 65162-356-50, 65162-356-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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 2 · 110 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
90 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
90 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
90 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
90 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
90 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
90 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
90 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
90 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
90 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
90 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
A202300-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23

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 13:18:302026-09A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23c2088c7a36db…
2026-09-14 22:38:342026-08A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-2384e616aacf4f…
2026-08-18 06:07:402026-07A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-233f01610625f2…
2019-09-15 20:21 UTC2019-09A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202300-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2011-12-233a93d1ddd44b…

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
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC877440fc-3afb-4123-a2e6-5cb48c74413c2024-10-25WarningsExact identifier
ndc (package): 65162-356-50
ndc (package): 65162-356-69
ndc (package): 65162-356-11
ndc (package): 65162-356-02
ndc (product): 65162-356
ndc11 (package): 65162035602
ndc11 (package): 65162035669
ndc11 (package): 65162035650
ndc11 (package): 65162035611
spl id: 53da63da-f301-44dc-902c-2c288304929f
spl set id: 877440fc-3afb-4123-a2e6-5cb48c74413c

Reported adverse events (FAERS/openFDA)#

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