CHILDRENS IBUPROFEN ORAL SUSPENSION

Generic: IBUPROFEN

PAI HoldingsManufacturer
ORALRoute
IBUPROFENActive Substance
2024-11-08Original Approval

CHILDRENS IBUPROFEN ORAL SUSPENSION is FDA application ANDA214789, sponsored by PAI HOLDINGS PHARM. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2020-10-22
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 m

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

Top Reported Reactions

1
DRUG INEFFECTIVE
15,725 reports
2
PAIN
15,074 reports
3
FATIGUE
14,489 reports
4
NAUSEA
13,521 reports
5
HEADACHE
12,104 reports
6
ARTHRALGIA
10,931 reports
7
DYSPNOEA
10,549 reports
8
VOMITING
10,009 reports
9
DIARRHOEA
9,724 reports
10
RASH
9,046 reports