NDC 29485-8060

TYLENOL COLD PLUS FLU SEVERE

Acetaminophen, Dextromethorphan Hbr,phenylephrine Hcl, Guaifenesin

TYLENOL COLD PLUS FLU SEVERE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Mechanical Servants Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID29485-8060_e4b87ba0-db76-2196-e053-2a95a90a074b
NDC29485-8060
Product TypeHuman Otc Drug
Proprietary NameTYLENOL COLD PLUS FLU SEVERE
Generic NameAcetaminophen, Dextromethorphan Hbr,phenylephrine Hcl, Guaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-18
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart341
Labeler NameMechanical Servants LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 29485-8060-4

2 POUCH in 1 PACKAGE (29485-8060-4) > 2 TABLET in 1 POUCH
Marketing Start Date2017-04-18
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TYLENOL COLD PLUS FLU SEVERE" or generic name "Acetaminophen, Dextromethorphan Hbr,phenylephrine Hcl, Guaifenesin"

NDCBrand NameGeneric Name
29485-8056TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
29485-8058TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
29485-8060TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
29485-8062TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
50269-402Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
50580-403TYLENOL COLD PLUS FLU SEVEREAcetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
52904-944Tylenol Cold Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
67414-402Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
73097-011Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
50580-402TYLENOL Cold Plus Flu SevereTYLENOL Cold Plus Flu Severe

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.