Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Childrens Ibuprofen Oral Suspension (IBUPROFEN)
Chain Drug Marketing Association, Inc. · suspension · NDC 63868-796
Listed in the FDA National Drug Code directory
Childrens Ibuprofen Oral Suspension is an over-the-counter medicine made available by Chain Drug Marketing Association, Inc., on the U.S. market since December 2020. It is marketed under an FDA approval (ANDA ANDA210602), 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.
What the genuine product looks like
From the official FDA label (version of Dec 23, 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 Ibuprofen Oral Suspension IBUPROFEN IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM
Text on the package panel: children's ibuprofen Oral Suspension (NSAID) For Ages 2 to 11 Years NDC 63868-796-04 QC QUALITY CHOICE See New Warnings Compare to the active ingredient in Children's Motrin ®** children's ibuprofen Oral Suspension (NSAID) 100 mg per 5 mL Pain Reliever/Fever Reducer 8 HRS Lasts up to 8 Hours For ages 2 to 11 years Alcohol Free Bubble Gum Flavor 4 fl oz (118 mL) Important: Read all product indormation before using Keep this box for important information. This product is intended for use in chil…
What it is for
Purpose Ibuprofen .... Pain reliever/fever reducer
Key warnings
Warnings Allergy alert: Ibuprofen may cause asevere 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 nonprescriptio…
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
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Recalls of this product
No FDA recalls are recorded for NDC 63868-796. Recalls are listed in FDA enforcement reports from 2004 onward.
Other recent recalls of ibuprofen
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
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.
Drug ineffective27,693 reports
Pain19,680 reports
Fatigue19,019 reports
Nausea18,569 reports
Headache16,768 reports
Arthralgia13,653 reports
Dyspnoea13,291 reports
Vomiting13,216 reports
Diarrhoea12,902 reports
Dizziness11,570 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 27,693 |
| Pain | 19,680 |
| Fatigue | 19,019 |
| Nausea | 18,569 |
| Headache | 16,768 |
| Arthralgia | 13,653 |
| Dyspnoea | 13,291 |
| Vomiting | 13,216 |
| Diarrhoea | 12,902 |
| 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.
Official listing
Brand
Childrens Ibuprofen Oral Suspension
Generic name
IBUPROFEN
Company
Chain Drug Marketing Association, Inc.
Form
suspension
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
63868-796
Active ingredients
Ibuprofen
100 mg/5mL
Packages (1)
The last part of the NDC identifies the pack size. Your box should show one of these.
63868-796-04 1 bottle in 1 carton (63868-796-04) / 118 ml in 1 bottle
Think your pack is fake?
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 10, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.