Physicians Care Ibuprofen

Manufacturer
Acme United Corporation
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:41:42

Label at a glance#

ProductPhysicians Care Ibuprofen
Active ingredientIBUPROFEN
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and pains associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever.

WARNINGS SECTION

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may

include:

■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ 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 or 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.

OTC - DO NOT USE SECTION

Do not use

■ if you have ever had an allergic reaction to 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

■ 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’ 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 ■ leg swelling ■ weakness in one part or side of body ■ slurred speech

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ redness or swelling is present in the painful area

■ any new or unexpected symptoms occur

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 at 20 weeks or later in pregnancy unless specifically 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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not use 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 24 hours, unless directed by a doctor.

Children under 12 years :

Do not give to children under 12 years of age.

OTHER SAFETY INFORMATION

Other information

■ read all product information before using

■ store at 20-25ºC (68-77°F)

■ avoid excessive heat 40°C (above 104°F)

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*,

microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*,

silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

Physicians Care Ibuprofen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Physicians Care® 90015

Ibuprofen

Pain Reliever/Fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Pill color may vary

Ibuptofen 200mg

100 Tablets (50 packets, 2 tablets each)

90015 Jpeg90015 Jpeg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN15
310965ibuprofen 200 MG Oral TabletSCD15
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY15

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
0924-0075-00Physicians Care Ibuprofen2 in 1 PACKETTABLET, COATED215
0924-0075-01Physicians Care Ibuprofen50 in 1 CARTONTABLET, COATED5015
0924-0075-02Physicians Care Ibuprofen2 in 1 PACKETTABLET, COATED215
0924-0075-02Physicians Care Ibuprofen125 in 1 CARTONTABLET, COATED12515
0924-0075-03Physicians Care Ibuprofen10 in 1 CARTONTABLET, COATED1015
0924-0075-04Physicians Care Ibuprofen6 in 1 CARTONTABLET, COATED615
0924-0075-05Physicians Care Ibuprofen20 in 1 CARTONTABLET, COATED2015

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
0924-00750924-0075-00, 0924-0075-01, 0924-0075-03, 0924-0075-02, 0924-0075-04, 0924-0075-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132025-09-08full-release2026-06-01 01:12:53

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
A075010-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

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 22:38:342026-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01f41ea6bd6efb…

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
Physicians Care IbuprofenIBUPROFEN 200MGAcme United Corporation490c1109-dad7-4135-e054-00144ff8d46c2025-10-31WarningsExact identifier
ndc (package): 0924-0075-03
ndc (package): 0924-0075-04
ndc (package): 0924-0075-00
ndc (package): 0924-0075-05
ndc (package): 0924-0075-02
ndc (package): 0924-0075-01
ndc (product): 0924-0075
ndc11 (package): 00924007500
ndc11 (package): 00924007505
ndc11 (package): 00924007504
ndc11 (package): 00924007503
ndc11 (package): 00924007501
ndc11 (package): 00924007502
spl id: 42788d11-1807-dfe4-e063-6294a90a477a
spl set id: 490c1109-dad7-4135-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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