Ibuprofen Capsules

Manufacturer
RITE AID CORPORATION | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-04-12
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:54

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure15 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache toothache  backache menstrual cramps muscular aches the common cold 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 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
*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
    • muscular aches
    • the common cold
    • 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 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. 

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

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 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

 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. 

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.

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 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD & C green no. 3,  gelatin (bovine),  polyethylene glycol, potassium hydroxide, purified water and sorbitol sorbitan solution.

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY:
RITE AID,
30 HUNTER LANE, CAMP HILL,
PA 17011
www.riteaid.com

MADE IN INDIA
 
Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (20 Capsules Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11822-4258-1
PAIN RELIEF
IBUPROFEN
CAPSULES, 200 mg
PAIN RELIEVER/FEVER REDUCER
(NSAID)

READ AND KEEP CARTON FOR COMPLETE                      
WARNINGS AND INFORMATION.                                   

 20
LIQUID FILLED CAPSULES



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (20 Capsules Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (20 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (20 Capsules Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREE           GLUTEN FREE             
FROM         PARABEN FREE        

Compare to the active                                                          
 
ingredient in Advil® Liqui-Gels®†

NDC 11822-4258-1

PAIN RELIEF
IBUPROFEN
CAPSULES, 200 mg
PAIN RELIEVER/FEVER REDUCER                                
(NSAID)                                                                                    

ACTUAL SIZE
 I200

READ AND KEEP CARTON FOR COMPLETE                      
WARNINGS AND INFORMATION.                                   


 20 
 LIQUID FILLED CAPSULES


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Container Carton)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Container Carton)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310964ibuprofen 200 MG Oral CapsulePSN3
310964ibuprofen 200 MG Oral CapsuleSCD3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4258-1Ibuprofen20 in 1 BOTTLECAPSULE203
11822-4258-1Ibuprofen1 in 1 CARTONCAPSULE13
11822-4258-2Ibuprofen40 in 1 BOTTLECAPSULE403
11822-4258-2Ibuprofen1 in 1 CARTONCAPSULE13
11822-4258-3Ibuprofen1 in 1 CARTONCAPSULE13
11822-4258-3Ibuprofen80 in 1 BOTTLECAPSULE803
11822-4258-4Ibuprofen160 in 1 BOTTLECAPSULE1603
11822-4258-5Ibuprofen300 in 1 BOTTLECAPSULE3003
11822-4258-6Ibuprofen200 in 1 BOTTLE, PLASTICCAPSULE2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4258IBUPROFEN CAPSULE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 9 package rows20230507_de158883-1175-18fc-e053-2995a90a3c96.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-425811822-4258-1, 11822-4258-2, 11822-4258-3, 11822-4258-4, 11822-4258-5, 11822-4258-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207753-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29

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 22:38:342026-08A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-2984e616aacf4f…
2026-08-18 06:07:402026-07A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207753-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2018-06-29f41ea6bd6efb…

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
IbuprofenIBUPROFENRITE AID CORPORATIONde158883-1175-18fc-e053-2995a90a3c962023-04-12WarningsExact identifier
ndc (package): 11822-4258-4
ndc (package): 11822-4258-2
ndc (package): 11822-4258-1
ndc (package): 11822-4258-6
ndc (package): 11822-4258-3
ndc (package): 11822-4258-5
ndc (product): 11822-4258
ndc11 (package): 11822425805
ndc11 (package): 11822425801
ndc11 (package): 11822425803
ndc11 (package): 11822425804
ndc11 (package): 11822425806
ndc11 (package): 11822425802
spl id: cf674005-a266-40ec-86eb-8195d1f3ebce
spl set id: de158883-1175-18fc-e053-2995a90a3c96

Reported adverse events (FAERS/openFDA)#

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