GUAIFENESIN AND PSEUDOEPHEDRINE HCL
Generic: GUAIFENESIN AND PSEUDOEPHEDRINE HCL
Granules India LtdManufacturer
ORALRoute
GUAIFENESINActive Substance
2022-08-22Original Approval
GUAIFENESIN AND PSEUDOEPHEDRINE HCL is FDA application ANDA216082, sponsored by GRANULES. 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 III2025-01-07
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI PharmaceuticalSuperpotent; sodium benzoate preservative
Class II2017-12-12
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method PharmaceMicrobial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkhol
Top Reported Reactions
1
DYSPNOEA
664 reports
2
DRUG INEFFECTIVE
639 reports
3
PNEUMONIA
618 reports
4
NAUSEA
591 reports
5
DIARRHOEA
563 reports
6
FATIGUE
562 reports
7
PAIN
496 reports
8
HEADACHE
459 reports
9
COUGH
452 reports
10
OFF LABEL USE
430 reports