boxed warning
Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 6 months to 23 months of age.
FDA label f33fa67d-b2fd-4daf-9b09-a799afd5f8a4
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 7f9d09db-170c-474c-b378-0bf4d499d769
- SPL ID
- f33fa67d-b2fd-4daf-9b09-a799afd5f8a4
- Version
- 6
- Effective date
- 2016-12-06
- Source export date
- 2026-08-17
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-17/f2a007a22a89560a66943d28521709913d039c2d0cd7e278faf1082cd194c72c/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
- Import run
- 20260818T065550Z
- Imported at
- 2026-08-18 07:12:18
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | f33fa67d-b2fd-4daf-9b09-a799afd5f8a4 | id | |
| spl set id | 7f9d09db-170c-474c-b378-0bf4d499d769 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 and seek medical help right away. Stomach bleeding warning: This product contains a NSAID, which may cause severe stomach bleeding. The chance is higher if the 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 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.