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 ID: 76281-312_e0cd0012-cae8-425e-9145-6c88a3d0951e
• NDC: 76281-312
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cough and Congestion Maximum Strength
• Generic Name: Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: AptaPharma Inc.
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/20mL; mg/20mL; mg/20mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 76281-312-26

237 mL in 1 BOTTLE (76281-312-26)

• Marketing Start Date: 2018-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76281-312-26 [76281031226]

Severe Cough and Congestion Maximum Strength LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-08-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL

OpenFDA Data

• SPL SET ID: 87b15122-aa6f-4964-9b32-79a501fe7d19
• Manufacturer:
  • AptaPharma Inc.
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• 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"

NDC	Brand Name	Generic Name
76281-312	Severe Cough and Congestion Maximum Strength	Severe Cough and Congestion Maximum Strength
11026-2780	Broncotron PED	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
11026-2790	Broncotron PED	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
30142-839	Childrens Mucus Relief	dextromethorphan HBr, guaifenesin, phenylephrine HCl
11822-0839	childrens mucus relief multi symptom cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-9839	childrens multi symptom cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
41163-839	equaline childrens mucus relief	dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0839	Good Sense Childrens Mucus Relief	dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0296	good sense tussin	dextromethorphan hbr, guaifenesin, phenylephrine hcl
37808-407	Mucus Multi Symptom Cold Relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
41250-137	Mucus Relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-6480	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
11822-3370	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
11822-3722	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
36800-037	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
41163-047	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
41163-037	Mucus Relief Severe Congestion Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-6048	Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
21130-817	Severe Congestion and Cough Relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
21130-272	Signature Care Childrens Multi Symptom Cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
36800-839	topcare childrens mucus relief multi symptom cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
36800-220	Topcare mucus relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
36800-296	topcare tussin cf max	dextromethorphan hbr, guaifenesin, phenylephrine hcl
15127-412	Tussin CF	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
11673-747	Up and Up mucus relief severe congestion and cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl