Ibuprofen

Manufacturer
Kinray, Inc. | Pharbest Pharmaceuticals, Inc.
Effective date
2016-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:28:07

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure16 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 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 consult a doctor

Storage and handling

Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature (20 o - 25 o C)  avoid excessive heat above 40 o C (104 o F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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:

WARNINGS AND PRECAUTIONS SECTION

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:

WARNINGS AND PRECAUTIONS SECTION

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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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 or asthma
  • 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
  • pain gets worse or last for more than 10 days
  • fever gets worse or last 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
  • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature (20o- 25oC) 
  • avoid excessive heat above 40oC (104oF)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc & titanium dioxide  

Questions? Adverse drug event call: (866)562-2756 Mon-Fri: 8 AM to 4 PM

OTC - QUESTIONS SECTION

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark MOTRIN® IB.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61715-168-50

*Compare to the active ingredient in MOTRIN® IB.

Preferred plus Pharmacy

IBUPROFEN 

Tablets  USP 200mg

Pain Reliever / Fever Reducer (NSAID)

50 Tablets

Preferred Plus Ibuprofen 200 mg Orange Tablet Package LabelPreferred Plus Ibuprofen 200 mg Orange Tablet Package Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-168-502025-05-20C16284748780-19d75b9d1-0ec1-f424-e053-dadaa90a57ceDrug Facts
61715-168-512025-05-20C16284748780-19d75b9d1-0ec1-f424-e053-dadaa90a57ceDrug Facts
61715-168-502020-01-31C16284748780-19d75b9d1-0ec1-f424-e053-dadaa90a57ceDrug Facts
61715-168-512020-01-31C16284748780-19d75b9d1-0ec1-f424-e053-dadaa90a57ceDrug Facts

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
61715-16861715-168-50, 61715-168-51

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 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
A091237-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-08

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 22:38:342026-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0884e616aacf4f…
2026-08-18 06:07:402026-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f01610625f2…
2019-09-15 20:21 UTC2019-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08f41ea6bd6efb…

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
719d27f5-40e3-4e71-9df6-504324e2e99d7cc53a7b-dff7-487a-b0e2-eef7f69b83ef2025-05-16WarningsExact identifier
spl set id: 7cc53a7b-dff7-487a-b0e2-eef7f69b83ef

Reported adverse events (FAERS/openFDA)#

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