Redicare Ibuprofen 200mg

Manufacturer
Redicare LLC
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:37

Label at a glance#

ProductRedicare Ibuprofen 200mg
Active ingredientIBUPROFEN
Label structure10 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

Storage and handling

■ store between 20-25 °C (68-77° F) ■ read all warnings and directions before use ■ do not use if packet is damaged or opened

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200mg (NSAID)*

Purpose

OTC - PURPOSE SECTION

fever reducer *nonsteroidal anti-inflammatory drug

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:

OTHER SAFETY INFORMATION

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:

ADVERSE REACTIONS SECTION

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:

WARNINGS AND PRECAUTIONS SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 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:

STORAGE AND HANDLING SECTION

■ store between 20-25 °C (68-77° F) ■ read all warnings and directions before use ■ do not use if packet is damaged or opened

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Questions or Comments?

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Call 1-866-561-5650. Monday through Friday 9AM – 5PM EST

Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PacketPacket

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71105-365-01Redicare Ibuprofen 200mg2 in 1 PACKETTABLET22
71105-365-02Redicare Ibuprofen 200mg50 in 1 BOXTABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71105-365REDICARE IBUPROFEN 200MG (IBUPROFEN 200MG) TABLET [REDICARE LLC]2Current NDC, 2 package rows20250306_2f0db953-33e2-1729-e063-6294a90af074.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71105-36571105-365-01, 71105-365-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

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 22:38:342026-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10f41ea6bd6efb…

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
Redicare Ibuprofen 200mgIBUPROFEN 200MGRedicare LLC2f0db953-33e2-1729-e063-6294a90af0742025-03-04Warnings, Adverse reactionsExact identifier
ndc (package): 71105-365-01
ndc (package): 71105-365-02
ndc (product): 71105-365
ndc11 (package): 71105036502
ndc11 (package): 71105036501
spl id: 2f85ecf2-17dd-54b6-e063-6294a90aa3ca
spl set id: 2f0db953-33e2-1729-e063-6294a90af074

Reported adverse events (FAERS/openFDA)#

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