Ibuprofen

Manufacturer
SUPERVALU INC.
Effective date
2019-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:32:00

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold 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 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

Storage and handling

read all warnings and directions before use store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40°C (104°F) retain carton for complete product information and warnings

Label contents#

Full prescribing information#

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

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 this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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 problem or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swellling
  • 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
adults and children 12 years and older
  • 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

STORAGE AND HANDLING SECTION

  • read all warnings and directions before use
  • store at 20º-25ºC (68º-77ºF)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • retain carton for complete product information and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-877-932-7948

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE®

compare to Motrin® IB active ingredient†

NDC 41163-212-03

Ibuprofen

Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 coated caplets**

**capsule-shaped tablets

image descriptionimage description

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
41163-21241163-212-02, 41163-212-03, 41163-212-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 1.

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
A091355-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-04-04

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043f01610625f2…
2019-09-15 20:21 UTC2019-09A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091355-001IBUPROFEN200MGTABLET / ORAL2011-04-04cb3db0bc1861…

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
cf45bb6c-4631-9986-e053-2a95a90aaaca7b2fcac9-e783-032e-e053-2a91aa0ac32c2021-10-26WarningsExact identifier
spl set id: 7b2fcac9-e783-032e-e053-2a91aa0ac32c