Ibutab

Manufacturer
Cintas Corporation | Ultra Seal Corporation | Ultratab Laboratories, Inc
Effective date
2021-01-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:57:46

Label at a glance#

ProductIbutab
Active ingredientIBUPROFEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient/Tablet Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose-Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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: 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
  • children under 12 years: ask a doctor

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
■ rash ■ skin reddening ■ 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
Do not use
■ if you have ever had an allergic reaction to any other pain
reliever/fever reducer
■ right before or after heart surgery
Ask a doctor before use if
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have problems or serious side effects from taking pain
relievers or fever reducers
■ you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, or asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ taking aspirin to prevent heart attack or stroke, because
ibuprofen may decrease this benefit of aspirin
■ taking any other drug
When using this product
■ 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
■ 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
■ 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.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax*, cellulose,
croscarmellose sodium*, DC yellow 10*, FDC blue 2*, FDC
red 40*, FDC yellow 6*, hydroxypropyl methylcellulose,
magnesium stearate, maltodextrin*, polyethylene glycol*,
polysorbate 80*, red iron oxide, silicon dioxide, sodium starch
glycolate*, starch*, talc*, titanium dioxide, triacetin*
*Contains one or more of these ingredients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibutab, 250 BoxIbutab, 250 Box

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-05042961-050-01, 42961-050-02, 42961-050-03, 42961-050-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079129-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-03-28

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 22:38:342026-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28f41ea6bd6efb…

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9cfb09b4-c98b-4205-85a7-119d56abe66bea2f8b53-2c50-4309-bf0d-756d416bbc142022-12-30WarningsExact identifier
spl set id: ea2f8b53-2c50-4309-bf0d-756d416bbc14

Reported adverse events (FAERS/openFDA)#

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