AeroTab Ibuprofen Tablets

Manufacturer
Aero Healthcare
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:14

Label at a glance#

ProductAeroTab Ibuprofen
Active ingredientIBUPROFEN
Label structure13 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient (in each tablet)
​Ibuprofen 200 mg (NSAID)*

PURPOSE

OTC - PURPOSE SECTION

Purpose


Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Uses:
Temporarily Relieves minor aches and pains
due to:
• Headache, toothaches, backache, menstrual cramps,
the common cold,
• muscular aches, minor pain of arthritis
Temporarily reduces fever

WARNINGS

WARNINGS SECTION

Warnings:

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 an dseek medical help right away.

Stomach bleeding warning: 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 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, stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

ASK A DOCTOR BEFORE USE

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or frever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, had a stroke, you are taking a diuretic

Ask a doctor or pharmacist before use if

  • you are under a doctor's care for any serious condition
  • Taking aspirin for a heart attack or stroke, because ibuprofen may decrease this benefit of asprin
  • taking any other drug

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

When using this product take with food or milk if stomach upset occurs

STOP USE AND ASK A DOCTOR

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
  • stomach pain that does not get better
  • 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 last more than 10 days
  • fever gets worse or last 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

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.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: In case of overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions: take only as directed - see Overdose warning.

Adults and children 12 years of age 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 hoiurs, unless directed by a doctor.

Children under 12 years ask a doctor. Do not take more than directed (see overdose warning). The smallest effective dose should be used.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20C to 25C (68F to 77F). Read all warnings and directions before use

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

corn starch, hypromellose, red iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch,silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin

Ibuprofen Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AeroTab

Ibuprofen USP 200mg

Anti-inflammatory

Fever reducer

Pain reliever

250

2 per packet

50 Tablet Box50 Tablet Box

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-133-01AeroTab Ibuprofen2 mg in 1 PACKETTABLET, COATED22
55305-133-02AeroTab Ibuprofen25 in 1 BOXTABLET, COATED252
55305-133-03AeroTab Ibuprofen25 in 1 BOXTABLET, COATED252
55305-133-04AeroTab Ibuprofen50 in 1 BOXTABLET, COATED502
55305-133-05AeroTab Ibuprofen125 in 1 BOXTABLET, COATED1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-133AEROTAB IBUPROFEN (IBUPROFEN TABLET) TABLET, COATED [AERO HEALTHCARE]2Current NDC, Legacy NDC, 5 package rows20250228_ddd0f7fb-ae4b-c584-e053-2a95a90a0984.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
55305-13355305-133-01, 55305-133-02, 55305-133-03, 55305-133-04, 55305-133-05

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
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

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 22:38:342026-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0184e616aacf4f…
2026-08-18 06:07:402026-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01f41ea6bd6efb…

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
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
ndc (package): 55305-133-02
ndc (package): 55305-133-03
ndc (package): 55305-133-04
ndc (package): 55305-133-01
ndc (package): 55305-133-05
ndc (product): 55305-133
ndc11 (package): 55305013302
ndc11 (package): 55305013301
ndc11 (package): 55305013305
ndc11 (package): 55305013304
ndc11 (package): 55305013303
spl id: 2f179532-9c6f-6ed3-e063-6294a90ab2b7
spl set id: ddd0f7fb-ae4b-c584-e053-2a95a90a0984

Reported adverse events (FAERS/openFDA)#

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