Gencare Ibuprofen Tablets 200 mg

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-06 06:10:35

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure17 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)* 

*nonsteroidal anti-inflammatory drug

Purposes

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.

SPL UNCLASSIFIED SECTION

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 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 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 SECTION

When using this product

■ take with food or milk if stomach upset occurs

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 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 SECTION

Keep out of reach of children. 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 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

Other information

OTHER SAFETY INFORMATION

■ read all warnings and directions before use

■ store between 20-25°C (68-77°F)

■ avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, pregelatinised starch, sodium starch glycolate, talc, titanium dioxide, triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

Call +1 (732) 994-2808 or email support@gencare.health

SPL UNCLASSIFIED SECTION

Distributed by: Gencare Consumer Products, LLC 40E Cotters Ln, Suite A,
East Brunswick, NJ 08816
www.gencare.health

†This product is neither manufactured nor distributed by Kenvue Brands LLC., owner of the registered trademark MOTRIN® IB.

NDC 72090-071-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L192-00 GC Ibuprofen-72090-071-01L192-00 GC Ibuprofen-72090-071-01

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372090005099GTIN-13: 0372090005099
EAN-13: 0372090005099
GTIN-12: 372090005099
UPC-A: 372090005099
GTIN storage (14 digits): 00372090005099
L192-00 GC Ibuprofen-72090-071-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-07172090-071-01

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-07-29daily-update2026-08-01 05:10:16

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#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091355-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-04-04

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
2026-09-14 22:38:342026-08A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0484e616aacf4f…
2026-08-18 06:07:402026-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043f01610625f2…
2019-09-15 20:21 UTC2019-09A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04f41ea6bd6efb…

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
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
ndc (package): 72090-071-01
ndc (product): 72090-071
ndc11 (package): 72090007101
spl id: 17d58272-a7be-4e15-b9e4-e3407a9e8e7f
spl set id: 291602fa-8ebe-4200-bba7-9798c90f8a50

Reported adverse events (FAERS/openFDA)#

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