NDC 76281-312

Severe Cough and Congestion Maximum Strength

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Cough and Congestion Maximum Strength is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aptapharma Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID76281-312_e0cd0012-cae8-425e-9145-6c88a3d0951e
NDC76281-312
Product TypeHuman Otc Drug
Proprietary NameSevere Cough and Congestion Maximum Strength
Generic NameDextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAptaPharma Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength20 mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76281-312-26

237 mL in 1 BOTTLE (76281-312-26)
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76281-312-26 [76281031226]

Severe Cough and Congestion Maximum Strength LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL

OpenFDA Data

SPL SET ID:87b15122-aa6f-4964-9b32-79a501fe7d19
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043543
  • NDC Crossover Matching brand name "Severe Cough and Congestion Maximum Strength" or generic name "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    76281-312Severe Cough and Congestion Maximum StrengthSevere Cough and Congestion Maximum Strength
    11026-2780Broncotron PEDDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    11026-2790Broncotron PEDDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    30142-839Childrens Mucus Reliefdextromethorphan HBr, guaifenesin, phenylephrine HCl
    11822-0839childrens mucus relief multi symptom colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-9839childrens multi symptom colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    41163-839equaline childrens mucus reliefdextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0839Good Sense Childrens Mucus Reliefdextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0296good sense tussindextromethorphan hbr, guaifenesin, phenylephrine hcl
    37808-407Mucus Multi Symptom Cold ReliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    41250-137Mucus ReliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-6480Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    11822-3370Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCL
    11822-3722Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCL
    36800-037Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    41163-047Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    41163-037Mucus Relief Severe Congestion CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-6048Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    21130-817Severe Congestion and Cough ReliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    21130-272Signature Care Childrens Multi Symptom Colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    36800-839topcare childrens mucus relief multi symptom colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    36800-220Topcare mucus reliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    36800-296topcare tussin cf maxdextromethorphan hbr, guaifenesin, phenylephrine hcl
    15127-412Tussin CFDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    11673-747Up and Up mucus relief severe congestion and coughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl

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