Haleon US Holdings LLC · suspension · NDC 0573-0174
CHILDRENS ADVIL is an over-the-counter medicine made available by Haleon US Holdings LLC, on the U.S. market since June 1996. It is marketed under an FDA approval (NDA NDA020589), so the FDA has reviewed its safety, effectiveness and manufacturing. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.
From the official FDA label (version of Feb 8, 2024). Compare the colour, shape, imprint and packaging with what you have. Any difference is a reason to ask a pharmacist before taking it.
Product data on the label: CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCROSE XANTHAN GUM Translucent, medium dark blue CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN ACETIC ACID BUTYLATED HYDROXYTOLUENE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C…
Text on the package panel: PRINCIPAL DISPLAY PANEL NDC 0573-0174-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours BLUE RASPBERRY! Blue Raspberry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Blue Raspberry
PURPOSE Fever reducer/Pain reliever
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 an 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 …
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
CGMP Deviations
Failed Tablet/Capsule Specifications
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
cGMP deviations: Temperature abuse
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
| Item | Value (reports) |
|---|---|
| Drug ineffective | 27,695 |
| Pain | 19,683 |
| Fatigue | 19,020 |
| Nausea | 18,574 |
| Headache | 16,765 |
| Arthralgia | 13,653 |
| Dyspnoea | 13,294 |
| Vomiting | 13,218 |
| Diarrhoea | 12,905 |
| Dizziness | 11,570 |
These counts are reports, not proof that the medicine caused the problem. Popular medicines get more reports simply because more people take them. They are useful for spotting what to watch for, not for comparing medicines.
Stop taking it, keep the pack and receipt, and show it to a pharmacist. In the U.S., report it to FDA MedWatch; elsewhere, to your national medicines regulator. How to spot a fake medicine.
Source: openFDA (U.S. Food and Drug Administration) drug directory, labels, enforcement reports and FAERS, retrieved Nov 8, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.