American Sales Company Ibuprofen Tablets 100 mg Drug Facts

Manufacturer
American Sales Company
Effective date
2019-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:34:24

Label at a glance#

ProductCareone ibuprofen junior strength
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Dosage and administration

• this product does not contain directions or complete warnings for adult use • do not give more than directed • find right dose on chart below. If possible, use weight to dose; otherwise use age. • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3

Storage and handling

• phenylketonurics: contains phenylalanine 6 mg per tablet • store between 20-25 ° C (68-77 ° F) • do not use if printed seal under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 your child:

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • takes 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.

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

OTC - DO NOT USE SECTION

  • if the child has ever had an allergic reaction to ibuprofen or 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 your child
  • child has a history of stomach problems, such as heartburn
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
  • child has asthma
  • child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • mouth or throat burning may occur; give with food or water
  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • child has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • the child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

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 right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day

Dosing Chart

Weight (lb)

Age (yr)

Tablets

under 24

under 2

ask a doctor

24-35

2-3

1

36-47

4-5

1 ½

48-59

6-8

2

60-71

9-10

2 ½

72-95

11

3

Other information

STORAGE AND HANDLING SECTION

  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • store between 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For Ages 2 to 11

Junior IBUPROFEN Tablets, 100 mg

Pain Reliever/Fever Reducer (NSAID)

Actual Size

Junior Strength

SEE NEW WARNINGS

OUR PHARMACISTS RECOMMEND

Lasts up to 8hrs

24 TABLETS

Grape-Flavored Chewables

521-of-ibuprofen.jpg
521-of-ibuprofen.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM1
IBUPROFENACTIVE MOIETYWK2XYI10QM1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR11
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SOYBEAN OILINACTIVE INGREDIENT241ATL177A1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6L1

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
41520-60041520-600-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 308 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FOR SUSPENSION / ORAL1875 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / SUBLINGUAL495 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED / ORAL2309 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii candidate
42 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii candidate
11 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER, FOR SUSPENSION / ORAL64 mgExact identifier — unii candidate
42 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9FILM, SOLUBLE / ORAL10 mgExact identifier — unii candidate
17 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE, EXTENDED RELEASE / ORAL288 mgExact identifier — unii candidate
11 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii candidate
17 equally ranked IID candidates
SUCCINIC ACIDSUCCINIC ACIDAB6MNQ6J6LINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION, EXTENDED RELEASE / ORAL0.08 mg/1mlExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii candidate
42 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET / SUBLINGUAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, GEL FORMING / DROPS / OPHTHALMIC4 mgExact identifier — unii candidate
65 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCCINIC ACIDSUCCINIC ACIDAB6MNQ6J6LSOLUTION / ORAL0.01 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR164 mgExact identifier — unii candidate
65 equally ranked IID candidates

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076359-001IBUPROFENIBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16
A076359-002IBUPROFENIBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1684e616aacf4f…
2026-09-14 22:38:342026-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1684e616aacf4f…
2026-08-18 06:07:402026-07A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076359-001IBUPROFEN50MGTABLET, CHEWABLE / ORAL2004-01-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076359-002IBUPROFEN100MGTABLET, CHEWABLE / ORALRS2004-01-1674a2ff9319b5…

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
f13b4d69-fc00-4bf6-9198-014b756f054a368e6d1b-8521-4ca6-9151-e69ea7660b042021-11-12WarningsExact identifier
spl set id: 368e6d1b-8521-4ca6-9151-e69ea7660b04

Reported adverse events (FAERS/openFDA)#

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