ADVIL ALLERGY SINUS

Generic: CHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCL

Haleon US Holdings LLCManufacturer
ORALRoute
CHLORPHENIRAMINE MALEATEActive Substance
2002-12-19Original Approval

ADVIL ALLERGY SINUS is FDA application NDA021441, sponsored by HALEON US HOLDINGS. 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 II2020-03-16
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning informat

Class II2020-03-16
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning informat

Class II2018-08-23
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 0794

Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the inst

Class III2014-02-26
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 U

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhy

Class II2020-03-16
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles ND

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning informat

Top Reported Reactions

1
DRUG INEFFECTIVE
25,292 reports
2
PAIN
17,662 reports
3
FATIGUE
17,409 reports
4
NAUSEA
16,476 reports
5
HEADACHE
14,909 reports
6
ARTHRALGIA
12,587 reports
7
DYSPNOEA
12,111 reports
8
VOMITING
11,644 reports
9
DIARRHOEA
11,629 reports
10
RASH
10,419 reports