Non-Drowsy Daytime Severe Cold Multi-Symptom

Product NDC
68210-4166
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Current FDA listing
Historical FDA.report record

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
68210-4166-11 BOTTLE in 1 CARTON (68210-4166-1) > 12 TABLET, FILM COATED in 1 BOTTLE2021-06-29NoCurrent

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
529bc1ae-a1b2-4984-8757-33ba65071441Non-Drowsy Daytime Severe Cold Multi-SymptomSpirit Pharmaceuticals LLC2024-12-13HUMAN OTC DRUG LABEL6