Ibuprofen Tablets, USP (NSAID) Pain Reliever/ Fever Reducer

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs
Effective date
2012-02-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:49:36

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

*Compared to the active ingredient of Advil®

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide.

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Indications & Usage

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain or arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • 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 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 NSAID (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 you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic
  • reached age 60 or older

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use ay increase the risk of heart attack or stroke

Stop use and ask a doctor if

  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear

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.

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 (1-800-222-1222) right away.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

  • 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 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 a 24-hour period
 Children under 12 years 
  • ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 20 – 25°C (68 – 77°F).
  • Read all warnings and directions before use

Questions or Comments?

SPL UNCLASSIFIED SECTION

Call 1-877-835-5472

Monday though Friday 9AM – 5PM EST.

SPL UNCLASSIFIED SECTION

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

SPL UNCLASSIFIED SECTION

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

Rev. 10-2008

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen Tabs,

USP 200mg

Principal Display Panel-Ibuprofen Tablets, USP 200mg
Principal Display Panel-Ibuprofen Tablets, USP 200mg

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-140-01EA - Each53746-1409b59909e-f012-4650-b0bb-48b24756969612013-02-11
53746-140-10EA - Each53746-140ec68f427-dec6-4174-929c-cfc07f475edc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM4
IBUPROFENACTIVE MOIETYWK2XYI10QM4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6754
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I304
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A4
POVIDONEINACTIVE INGREDIENTFZ989GH94E4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A24
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP4

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
0615-35270615-3527-39
53746-140

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form

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
A071333-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-02-17

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 22:38:342026-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1784e616aacf4f…
2026-08-18 06:07:402026-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCee241be0-35f8-4789-a71f-98de31d6a5902023-12-31WarningsExact identifier
ndc (product): 53746-140
915618ec-ed9f-4094-a144-dfae11a606901b2ab0e2-ed21-4df8-bed2-55728a505c7d2012-02-24WarningsExact identifier
spl set id: 1b2ab0e2-ed21-4df8-bed2-55728a505c7d

Reported adverse events (FAERS/openFDA)#

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