FDA.reportPublic FDA data

Ibuprofen

Manufacturer
Safetec of America, Inc.
Effective date
2019-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:27

Label at a glance#

ProductIbuprofen
Active ingredientIbuprofen
Label structure13 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 lake more than directed the smallest effective dose should be used 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 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
  • 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

SPL UNCLASSIFIED SECTION

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

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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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 lake more than directed
  • the smallest effective dose should be used
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 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)
  • do not use if foil inner seal is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch, glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-456-7077

Principal Display Panel - 200 mg Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Ibuprofen Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)*

GLUTEN-FREE
2 Coated Tablets

Principal Display Panel - 200 mg Pouch Label
Principal Display Panel - 200 mg Pouch Label

Principal Display Panel – 50 Pouches Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec®
of America, Inc.

*Compare to the active ingredient in Advil®

NDC 61010-4411-1

Ibuprofen

Ibuprofen Tablets USP, 200 mg

PUSH TO OPEN

Dispense through opening

Pain Reliever/Fever Reducer (NSAID)*

  • Relieves minor aches and pains
  • Fever reducer
  • Coated tablets

GLUTEN-FREE

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per pouch

Principal Display Panel – 50 Pouches Carton Label
Principal Display Panel – 50 Pouches Carton Label

Principal Display Panel – 100 Pouches Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec®
of America, Inc.

*Compare to the active ingredient in Advil®

NDC 61010-4411-2

Ibuprofen

Ibuprofen Tablets USP, 200 mg - Pain Reliever/Fever Reducer (NSAID)*

GLUTEN-FREE

  • Relieves minor aches and pains
  • Fever reducer
  • Coated tablets

PUSH TO OPEN

Dispense through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per pouch

Principal Display Panel – 100 Pouches Carton Label
Principal Display Panel – 100 Pouches Carton Label

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
61010-4411-02024-01-30C16284748780-11030e365-005e-111a-e063-dadaa90a10e2eda3745a-1009-4a89-8ec6-c7d26d7e7275
61010-4411-12024-01-30C16284748780-11030e365-005e-111a-e063-dadaa90a10e2eda3745a-1009-4a89-8ec6-c7d26d7e7275
61010-4411-22024-01-30C16284748780-11030e365-005e-111a-e063-dadaa90a10e2eda3745a-1009-4a89-8ec6-c7d26d7e7275

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4411-0Ibuprofen2 in 1 POUCHTABLET22
61010-4411-1Ibuprofen50 in 1 CARTONTABLET502
61010-4411-2Ibuprofen100 in 1 CARTONTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4411IBUPROFEN TABLET [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200125_eda3745a-1009-4a89-8ec6-c7d26d7e7275.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
61010-441161010-4411-0, 61010-4411-1, 61010-4411-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
IbuprofenWK2XYI10QMACTIB
Silicon DioxideETJ7Z6XBU4IACT
Ferric Oxide Red1K09F3G675IACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
Polyvinyl alcohol, Unspecified532B59J990IACT
Povidone K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
Stearic acid4ELV7Z65APIACT
Sodium Starch Glycolate Type A Potato5856J3G2A2IACT
Talc7SEV7J4R1UIACT
Titanium dioxide15FIX9V2JPIACT

Source Document#

Source XML

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
f4128377-a30a-4fc5-8e9f-e3e4eccb798eeda3745a-1009-4a89-8ec6-c7d26d7e72752019-12-30WarningsExact identifier
spl id: f4128377-a30a-4fc5-8e9f-e3e4eccb798e
spl set id: eda3745a-1009-4a89-8ec6-c7d26d7e7275

Reported adverse events (FAERS/openFDA)#

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