Ibuprofen

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2026-07-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-28 05:10:13

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure18 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 adults and children 12 years and over: 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: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 pains 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

Heart attack and stroke warning: 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.

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if 

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from takin 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

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
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • 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

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 at 20 weeks or later in 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: 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: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 20˚-25˚C (68˚-77˚F)
  • avoid excessive heat above 40°C (104°F)
  • **Contains FD&C Yellow No. 5 (tartrazine) as a color

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C yellow #5 (tartrazine)**, FD&C yellow #6, iron oxide red, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc,titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen 200 mg

Carton

Ibuprofen brown cartonIbuprofen brown carton

Label

Ibuprofen brown labelIbuprofen brown label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130611419406125GTIN-13: 0611419406125
EAN-13: 0611419406125
GTIN-12: 611419406125
UPC-A: 611419406125
GTIN storage (14 digits): 00611419406125
Ibuprofen Brown Carton.jpg
QR code linkQR Codewww.shieldpharmacorp.com/Ibuprofen Brown Carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-016583059-0165-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207095-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2017-05-05
A207095-002IBUPROFENIBUPROFEN200MGTABLET / ORAL2018-08-21

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0584e616aacf4f…
2026-09-14 22:38:342026-08A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2184e616aacf4f…
2026-08-18 06:07:402026-07A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207095-002IBUPROFEN200MGTABLET / ORAL2018-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207095-001IBUPROFEN200MGTABLET / ORAL2017-05-05bb7c543d1eb4…

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
IbuprofenIBUPROFENShield Pharmaceuticals Corp1ca722bb-940e-4b3e-9561-d87e2feb1ff82026-07-24WarningsExact identifier
ndc (package): 83059-0165-3
ndc (product): 83059-0165
ndc11 (package): 83059016503
spl id: 575dbcb4-5dfe-a2b6-e063-6294a90a24b5
spl set id: 1ca722bb-940e-4b3e-9561-d87e2feb1ff8

Reported adverse events (FAERS/openFDA)#

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