Ibuprofen

Manufacturer
BIG LOTS STORES, INC.
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:08

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure19 sections

Indications and uses

temporarily relieves minor aches and pains 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 adult and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor chlidren under 12 years: ask a doctor

Storage and handling

each capsule contains: potassium 20 mg Read all warnings and directions before use. Keep carton. Store at 20-25°C (68-77°F) Avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active Ingridient

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Solubulised Ibuprofen equal to 200 mg Ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever

Allergy Alert

WARNINGS SECTION

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:

  • hives
  • facial sewlling
  • asthama (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

WARNINGS 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 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

WARNINGS SECTION

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.

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, 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

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
  • slurred speech
  • weakness in one part or side of body
  • 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

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

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used

adult and children 12 years and over:

  • take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor

chlidren under 12 years:

  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: potassium 20 mg
  • Read all warnings and directions before use. Keep carton.
  • Store at 20-25°C (68-77°F)
  • Avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, FD&C yellow no. 6, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40 count40 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310964ibuprofen 200 MG Oral CapsulePSN2
310964ibuprofen 200 MG Oral CapsuleSCD2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50594-146-042022-01-28C16284748780-1d6a99b39-4ce4-a426-e053-dadaa90af4c2Ibuprofen Capsules, 200 mg Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50594-146-04Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-146IBUPROFEN CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]2Legacy NDC, 1 package rows20201231_862d926f-a6d3-31e1-e053-2991aa0a6454.zip

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
50594-14650594-146-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
A206999-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206999-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21f41ea6bd6efb…

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
b7b4f650-ec1a-9f62-e053-2995a90aa17a862d926f-a6d3-31e1-e053-2991aa0a64542020-12-30WarningsExact identifier
spl id: b7b4f650-ec1a-9f62-e053-2995a90aa17a
spl set id: 862d926f-a6d3-31e1-e053-2991aa0a6454

Reported adverse events (FAERS/openFDA)#

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