Ibuprofen Tablets USP 200 mg

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:41:48

Label at a glance#

ProductAssured Ibuprofen
Active ingredientIBUPROFEN
Label structure21 sections

Indications and uses

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

Dosage and administration

¬ do not take more than directed ¬ the smallest effective dose should be used ¬ do not take longer than 10 days, unless directed by a doctor (see Warnings) ¬ adults and children 12 years and over: 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:...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each 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 pain 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 a
nonsteroidal anti-inflammatory drug (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

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning NSAID's except
aspirin increases 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 to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

¬ the 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

¬ 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

When using this product

OTC - WHEN USING SECTION

¬ take with food or milk if stomach upset occurs
¬ the risk of heart attack or stroke may increase if you
use more than directed or for longer than directed

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:

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

OTC - STOP USE SECTION

¬ chest pain ¬ trouble breathing
¬ leg swelling ¬ slurred speech
¬ weakness in one part or side of body
¬ 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 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.

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
¬ do not take longer than 10 days, unless directed by a
doctor (see Warnings)
¬ adults and children 12 years and over: 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

Other information

OTHER SAFETY INFORMATION

¬ read all warnings and directions before use.
¬ store between 20°-25°C (68°-77°F)
¬ avoid excessive heat above 40°C (104°F)

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

Inactive ingredients

INACTIVE INGREDIENT SECTION


colloidal silicon
dioxide, FD&C yellow no. 6, maize starch, polyethylene
glycol, polyvinyl alcohol, povidone k30,
pregelatinized starch, sodium starch glycolate, stearic
acid, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen

Ibuprofen Tablets 200 mg -

Pain reliever/fever reducer (NSAID)

LabelLabel

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN6
310965ibuprofen 200 MG Oral TabletSCD6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68210-4139-4Assured Ibuprofen40 in 1 BOTTLETABLET, FILM COATED406
68210-4139-4Assured Ibuprofen1 in 1 CARTONTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4139ASSURED IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 2 package rows20241212_119263b5-c3b7-46dc-a3bd-9893bfd24628.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-413968210-4139-4

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

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
A202312-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2016-10-07

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
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2026-09-14 22:38:342026-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073f01610625f2…
2019-09-15 20:21 UTC2019-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07ea99ee380514…
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2024-02-18 07:12 UTC2024-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073a93d1ddd44b…

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
Assured IbuprofenIBUPROFENSpirit Pharmaceuticals LLC119263b5-c3b7-46dc-a3bd-9893bfd246282024-12-10WarningsExact identifier
ndc (package): 68210-4139-4
ndc (product): 68210-4139
ndc11 (package): 68210413904
spl id: 28ef5535-36c5-ed54-e063-6394a90aefc6
spl set id: 119263b5-c3b7-46dc-a3bd-9893bfd24628

Reported adverse events (FAERS/openFDA)#

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