NDC 15127-503

Cold and Flu Severe

Acetaminophen, Phenylephrine Hcl, Guaifenesin, Dextromethorphan Hbr

Cold and Flu Severe is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by L&r Distributors, Inc.. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Guaifenesin; Dextromethorphan Hydrobromide.

• Product ID: 15127-503_b6def532-14bb-42ed-8c8b-ba8e15b5f61d
• NDC: 15127-503
• Product Type: Human Otc Drug
• Proprietary Name: Cold and Flu Severe
• Generic Name: Acetaminophen, Phenylephrine Hcl, Guaifenesin, Dextromethorphan Hbr
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-08-04
• Marketing End Date: 2021-09-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: L&R Distributors, Inc.
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N

Packaging

NDC 15127-503-08

2 BLISTER PACK in 1 CARTON (15127-503-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2005-08-04
• Marketing End Date: 2021-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15127-503-08 [15127050308]

Cold and Flu Severe TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-08-04
• Marketing End Date: 2021-09-10

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 53154b24-a84d-44bb-9037-3327c867df40
• Manufacturer:
  • L&R Distributors, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988
• UPC Code:
  • 0015127026819

NDC Crossover Matching brand name "Cold and Flu Severe" or generic name "Acetaminophen, Phenylephrine Hcl, Guaifenesin, Dextromethorphan Hbr"

NDC	Brand Name	Generic Name
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-663	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49348-118	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
50804-163	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
53943-163	COLD and FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
53943-186	COLD AND FLU SEVERE	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
68016-512	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
72476-163	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
11822-5031	Cold and Flu Severe	Cold and Flu Severe
49035-053	Cold and Flu severe	Cold and Flu severe
55315-504	Cold and Flu Severe	Cold and Flu Severe
55910-054	Cold and Flu Severe	Cold and Flu Severe
0363-0640	Cold and Flu Severe	Cold and Flu Severe
50804-503	Cold and Flu Severe	Cold and Flu Severe
79395-503	Cold and Flu Severe	Cold and Flu Severe
15127-503	Cold and Flu	Acetaminophen, Phenylephrine HCl, Guaifenesin, Dextromethorphan HBr