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 • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise use age. • use only enclosed dosing cup. Do not use any other dosing device. • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day • replace original bottle cap to mai...
• each 5 mL contains: sodium 2 mg • do not use if printed neckband is broken or missing • store at 20-25°C (68-77°F) • do not freeze
Ibuprofen 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:
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Weight (lb) | Age (yr) | Dose (mL)** |
under 24 lbs | under 2 years | ask a doctor |
24-35 lbs | 2-3 years | 5 mL |
36-47 lbs | 4-5 years | 7.5 mL |
48-59 lbs | 6-8 years | 10 mL |
60-71 lbs | 9-10 years | 12.5 mL |
72-95 lbs | 11 years | 15 mL |
anhydrous citric acid, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial bubblegum flavors, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum
1-800-719-9260
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 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 |
|---|---|
| 69256-166 | 69256-166-26 |
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 |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RECTAL | 904 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVENOUS | 0.5 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / RECTAL | 315 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION / ORAL | 20000 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRA-ARTICULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / BUCCAL | 30 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAMUSCULAR | 4 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY / NASAL | 0.01 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 900 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 |
|---|---|---|---|---|---|---|---|
| A074937-001 | CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 |
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 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | 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 |
|---|---|---|---|---|---|---|
| 316b05e8-fa2f-4f5f-a1ea-46700503d917 | b04c2ae1-1a03-42d2-86c7-592dcd13018c | 2023-12-14 | Warnings | b04c2ae1-1a03-42d2-86c7-592dcd13018c |
Adverse event summaries are temporarily unavailable. Other product information remains available.