IBUPROFEN TABLETS USP 200MG ROUND BROWN

Manufacturer
TIME CAP LABORATORIES,INC | MARKSANS PHARMA LIMITED
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:03:05

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure24 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)*
* nonstreoidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Pain reliever / Fever reducer

INDICATIONS & USAGE SECTION

Uses
temporarily relieves minor aches and pains due to:

o headache
o toothache
o backache
o menstrual cramps
o the common cold
o muscular aches
o minor pain of arthritis

temporarily reduces fever

WARNINGS SECTION

Warnings

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 SECTION

Do not use

  • if you have ever had an allergic reaction to ibuprofen or 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 problem or stroke:

  • chest pain
  • trouble breathing
  • weakness in one part or side of the 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).

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 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

SPL UNCLASSIFIED SECTION

Other information

  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600R-Timely-Ibuprofen Caplet-50s-Label600R-Timely-Ibuprofen Caplet-50s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600R-Timely-Ibuprofen Caplet-100s-Label600R-Timely-Ibuprofen Caplet-100s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600R-Timely-Ibuprofen Caplet-500s-Label600R-Timely-Ibuprofen Caplet-500s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

601R-Timely-Ibuprofen Tablet-50s-Label601R-Timely-Ibuprofen Tablet-50s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

601R-Timely-Ibuprofen Tablet-100s-Label601R-Timely-Ibuprofen Tablet-100s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

601R-Timely-Ibuprofen Tablets-100s-Label601R-Timely-Ibuprofen Tablets-100s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

601R-Timely-Ibuprofen Tablets-200s-Label601R-Timely-Ibuprofen Tablets-200s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

601R-Timely-Ibuprofen Tablets-500s-Label601R-Timely-Ibuprofen Tablets-500s-Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

601R-Timely-Ibuprofen Tablets-1000s-Label601R-Timely-Ibuprofen Tablets-1000s-Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN12
310965ibuprofen 200 MG Oral TabletSCD12
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY12

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
49483-114-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100012
49483-114-17Ibuprofen200 in 1 BOTTLETABLET, FILM COATED20012
49483-114-50Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50012
49483-114-73Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10012
49483-600-01IBUPROFEN100 in 1 BOTTLETABLET, FILM COATED10012
49483-600-05IBUPROFEN50 in 1 BOTTLETABLET, FILM COATED5012
49483-600-50IBUPROFEN500 in 1 BOTTLETABLET, FILM COATED50012
49483-601-00IBUPROFEN6500 in 1 BAGTABLET, FILM COATED650012
49483-601-01IBUPROFEN100 in 1 BOTTLETABLET, FILM COATED10012
49483-601-05IBUPROFEN50 in 1 BOTTLETABLET, FILM COATED5012
49483-601-10IBUPROFEN1000 in 1 BOTTLETABLET, FILM COATED100012
49483-601-50IBUPROFEN500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-601-01EA - Each49483-601fd134b1c-8ff4-4996-ac8d-d83ea5512c3812016-10-06
49483-601-10EA - Each49483-60104788942-bccc-4d4b-ad63-76b3906a3d5b12017-12-14

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML · Source PDF

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 1.

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
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01cb3db0bc1861…

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
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
ndc (package): 49483-114-73
ndc (package): 49483-114-50
ndc (package): 49483-600-01
ndc (package): 49483-601-00
ndc (package): 49483-601-50
ndc (package): 49483-601-10
ndc (package): 49483-114-10
ndc (package): 49483-601-05
ndc (package): 49483-600-05
ndc (package): 49483-114-17
ndc (package): 49483-601-01
ndc (package): 49483-600-50
ndc (product): 49483-114
ndc (product): 49483-601
ndc (product): 49483-600
ndc11 (package): 49483060001
ndc11 (package): 49483060005
ndc11 (package): 49483060050
ndc11 (package): 49483060110
ndc11 (package): 49483060150
ndc11 (package): 49483060101
ndc11 (package): 49483011417
ndc11 (package): 49483060100
ndc11 (package): 49483011473
ndc11 (package): 49483011410
ndc11 (package): 49483011450
ndc11 (package): 49483060105
spl id: 375d8923-4e92-d631-e063-6294a90a20eb
spl set id: f58d35f9-e44b-417b-98ce-0766b537cd2f