Ibuprofen Tablets 200mg

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:39

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure17 sections

Indications and uses

Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches 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 4-6 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 of age Ask a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, 200mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Releiver / Fever Reducer

nonsteroidal anti-inflammatory drug

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

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to

  • Common cold
  • headache
  • minor pain of arthritis
  • toothache
  • backache
  • muscular aches
  • menstrual cramps

temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert

Ibuprofen may cause severe allergic reactions, 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 a NSAID, which may cause severe stomach bleeding. The chances are higher if you:

  • are age 60 or older
  • have stomach ulcers or bleeding problems
  • take 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 or 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.

Contains FD+C Yellow No. 5 (tartrazine) as a color additive

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 the benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

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 (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 4-6 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 of age

  • Ask a doctor

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 lsats 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 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.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 20ºC - 25ºC (68ºF - 77ºF)
  • Do not use if printed packet is torn or punctured.

TAMPER EVIDENTchild resistant packets. Do not use any opened or torn packets.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.

When using this product

OTC - WHEN USING SECTION

Take with food or milk if stomach upset occurs

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®

Reorder No. 2022

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2026 GLOBE IBUPROFEN TABLET 200MG BOTTLE REV04 060525 CDER2026 GLOBE IBUPROFEN TABLET 200MG BOTTLE REV04 060525 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN1
310965ibuprofen 200 MG Oral TabletSCD1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1

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
69396-172-01Ibuprofen1000 in 1 BOTTLETABLET10001

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-17269396-172-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207095-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2017-05-05
A207095-002IBUPROFENIBUPROFEN200MGTABLET / ORAL2018-08-21

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0584e616aacf4f…
2026-09-14 22:38:342026-08A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2184e616aacf4f…
2026-08-18 06:07:402026-07A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05bb7c543d1eb4…

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
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC37299475-e2f3-de26-e063-6394a90ad62d2025-06-09WarningsExact identifier
ndc (package): 69396-172-01
ndc (product): 69396-172
ndc11 (package): 69396017201
spl id: 3729a3d5-0ccd-378f-e063-6294a90aa65c
spl set id: 37299475-e2f3-de26-e063-6394a90ad62d

Reported adverse events (FAERS/openFDA)#

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