NDC 51013-169

Severe Sinus Congestion Allergy and Cough Formula

Acetaminophen, Dextromethorphan Hydrobromide , Doxylamine Succinate, Phenylephrine Hydrochloride

Severe Sinus Congestion Allergy and Cough Formula is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 51013-169_a2039262-9959-4098-8ad8-a35d343c9ecc
• NDC: 51013-169
• Product Type: Human Otc Drug
• Proprietary Name: Severe Sinus Congestion Allergy and Cough Formula
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide , Doxylamine Succinate, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-29
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: PuraCap Pharmaceutical LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51013-169-08

2 BLISTER PACK in 1 CARTON (51013-169-08) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2016-06-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51013-169-08 [51013016908]

Severe Sinus Congestion Allergy and Cough Formula CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-29

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 36a4ec1f-50c3-4d61-ada9-987ccad3563c
• Manufacturer:
  • PuraCap Pharmaceutical LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1297288

NDC Crossover Matching brand name "Severe Sinus Congestion Allergy and Cough Formula" or generic name "Acetaminophen, Dextromethorphan Hydrobromide , Doxylamine Succinate, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
51013-169	Severe Sinus Congestion Allergy and Cough Formula	Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride
63868-227	Severe Sinus Congestion Allergy and Cough Formula	Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride
0280-0097	Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels	Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride