FDA.reportPublic FDA data

Ibuprofen Tablets, USP 200 mg

Manufacturer
AiPing Pharmaceutical, Inc. | Anshi Pharmaceutical (Zhongshan) Inc.
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:40

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

store between 20-25°C (68-77°F) do not use if the inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing

Label contents#

Full prescribing information#

Important

SPL UNCLASSIFIED SECTION

Read all product information before using. Keep this box for important 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

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

Stomach bleeding warning:

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:

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.

Brown Film-Coated Caplets contain FD+C Yellow No. 5 (tartrazine) as a color additive

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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
OTC - ASK DOCTOR/PHARMACIST SECTION

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
  • under a doctor's care for any serious condition
  • 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 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

  • store between 20-25°C (68-77°F)
  • do not use if the inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-374-0016 Monday through Friday 9AM - 5PM EST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen tablets are available in the following colors and sizes:

Orange, Round-shaped Tablet, debossed with BI 02

Bottles of 24 NDC 11788-002-07

Bottles of 1000 NDC 11788-002-10

ibu 200 orangeibu 200 orange

White, Round-shaped Tablet, debossed with BI 04

Bottles of 24 NDC 11788-004-07

Bottles of 1000 NDC 11788-004-10

whitewhite

Brown, Round-shaped Tablet, debossed with BI 06

Bottles of 24 NDC 11788-006-07

Bottles of 1000 NDC 11788-006-10

brownbrown

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN2
310965ibuprofen 200 MG Oral TabletSCD2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2

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
11788-002-072024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg
11788-002-102024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg
11788-004-072024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg
11788-004-102024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg
11788-006-072024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg
11788-006-102024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-002-07Ibuprofen24 in 1 BOTTLETABLET, FILM COATED242
11788-002-07Ibuprofen1 in 1 CARTONTABLET, FILM COATED12
11788-002-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10002
11788-004-07Ibuprofen1 in 1 CARTONTABLET, FILM COATED12
11788-004-07Ibuprofen24 in 1 BOTTLETABLET, FILM COATED242
11788-004-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10002
11788-006-07Ibuprofen24 in 1 BOTTLETABLET, FILM COATED242
11788-006-07Ibuprofen1 in 1 CARTONTABLET, FILM COATED12
11788-006-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11788-002IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.]2Legacy NDC, 3 package rows20190301_764ff65b-e6de-62e5-e053-2991aa0a94e5.zip
11788-004IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.]2Legacy NDC, 3 package rows20190301_764ff65b-e6de-62e5-e053-2991aa0a94e5.zip
11788-006IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.]2Legacy NDC, 3 package rows20190301_764ff65b-e6de-62e5-e053-2991aa0a94e5.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11788-00211788-002-07, 11788-002-10
11788-00411788-004-07, 11788-004-10
11788-00611788-006-07, 11788-006-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
POLYVINYL ALCOHOL532B59J990IACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
POLYVINYL ALCOHOL532B59J990IACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FERRIC OXIDE RED1K09F3G675IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
POLYVINYL ALCOHOL532B59J990IACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB

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.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-2174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-213f01610625f2…
2019-09-15 20:21 UTC2019-09A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-21ea99ee380514…

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
7c60fc45-3a27-9e52-e053-2a91aa0ab81e764ff65b-e6de-62e5-e053-2991aa0a94e52018-12-06WarningsExact identifier
spl id: 7c60fc45-3a27-9e52-e053-2a91aa0ab81e
spl set id: 764ff65b-e6de-62e5-e053-2991aa0a94e5