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Currently there are several approved formulations containing including NDA 05-213 1943 and NDA 19-111 1987. The other two active ingredients guaifenesin and pseudoephedrine are recognized OTC monograph drugs 21 CFR 341. C4H6O6. 2 H2O/494. 5 Drug Class Narcotic analgesic and antitussive Related NDA 19-111 Suspension NDA 5-213 Tablets and Syrup NDA 19-410 Syrup DMF Structure Generic Name Pseudoephedrine HCl Drug Class Nasal decongestant Related NDA 21-585 Mucinex D guaifenesin with...
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