Indications and uses
temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed measuring cup if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance ...
Drug Facts
Ibuprofen, USP 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Dosing Chart
| Weight (lb) | Age (yr) | Dose (tsp or mL) |
| under 2 years | ask a doctor | |
| 24-35 lbs | 2-3 years | 1 tsp or 5 mL |
| 36-47 lbs | 4-5 years | 1 ½ tsp or 7.5 mL |
| 48-59 lbs | 6-8 years | 2 tsp or 10 mL |
| 60-71 lbs | 9-10 years | 2 ½ tsp or 12.5 mL |
| 72-95 lbs | 11 years | 3 tsp or 15 mL |
artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum
1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-263 | 55319-263-94 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE 2910 (4000 MPA.S) | RN3152OP35 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ALCOHOL | 3K9958V90M | CNTM |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SHAMPOO / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAMUSCULAR | 4 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAVENOUS | 1170 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAMUSCULAR | 5 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SWAB / TOPICAL | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 53 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | OINTMENT / TOPICAL | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LOTION / TOPICAL | 0.85 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074916-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 84348dd8-cae2-4ff5-b24d-0a9f463c45c0 | e24c517b-c61f-40a7-b817-dcfaab22e09f | 2018-01-22 | Warnings | 84348dd8-cae2-4ff5-b24d-0a9f463c45c0 e24c517b-c61f-40a7-b817-dcfaab22e09f |
Adverse event summaries are temporarily unavailable. Other product information remains available.