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#
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
Drug Facts
Active Ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)*
PURPOSE
Purpose
Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer
*nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE
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:
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
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
When using this product take with food or milk if stomach upset occurs
STOP USE AND ASK A DOCTOR
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
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
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
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 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 Ingredients:
corn starch, hypromellose, red iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch,silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin
Ibuprofen Package
AeroTab
Ibuprofen USP 200mg
Anti-inflammatory
Fever reducer
Pain reliever
250
2 per packet
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55305-133-02 | 2025-02-26 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-03 | 2025-02-26 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-04 | 2025-02-26 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-05 | 2025-02-26 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
| 55305-133-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-55f5-111a-e063-dadaa90a10e2 | AeroTab Ibuprofen Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55305-133-01 | AeroTab Ibuprofen | 2 mg in 1 PACKET | TABLET, COATED | 2 | 2 | |
| 55305-133-02 | AeroTab Ibuprofen | 25 in 1 BOX | TABLET, COATED | 25 | 2 | |
| 55305-133-03 | AeroTab Ibuprofen | 25 in 1 BOX | TABLET, COATED | 25 | 2 | |
| 55305-133-04 | AeroTab Ibuprofen | 50 in 1 BOX | TABLET, COATED | 50 | 2 | |
| 55305-133-05 | AeroTab Ibuprofen | 125 in 1 BOX | TABLET, COATED | 125 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- AeroTab Ibuprofen
- ibuprofen tablet
- STARCH, CORN
- TALC
- IBUPROFEN
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL 1000
- POLYVINYL ALCOHOL (100000 MW)
- MICROCRYSTALLINE CELLULOSE
- TITANIUM DIOXIDE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55305-133 | 55305-133-01, 55305-133-02, 55305-133-03, 55305-133-04, 55305-133-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| POLYVINYL ALCOHOL (100000 MW) | 949E52Z6MY | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091239-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AeroTab Ibuprofen | IBUPROFEN TABLET | Aero Healthcare | ddd0f7fb-ae4b-c584-e053-2a95a90a0984 | 2025-02-26 | Warnings | 55305-133-02 55305-133-03 55305-133-04 55305-133-01 55305-133-05 55305-133 55305013302 55305013301 55305013305 55305013304 55305013303 2f179532-9c6f-6ed3-e063-6294a90ab2b7 ddd0f7fb-ae4b-c584-e053-2a95a90a0984 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
