NDC 49738-787

Severe Cold and Flu Relief

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Severe Cold and Flu Relief is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Smart Sense (kmart). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 49738-787_7e446be0-e68a-a10a-e053-2a91aa0adf52
• NDC: 49738-787
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Flu Relief
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: SMART SENSE (KMART)
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49738-787-24

2 BLISTER PACK in 1 CARTON (49738-787-24) > 12 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2015-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49738-787-24 [49738078724]

Severe Cold and Flu Relief TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-10-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: a3ec44ee-90b6-42ab-96a2-52728a623d35
• Manufacturer:
  • SMART SENSE (KMART)
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988
• UPC Code:
  • 0883967393473

NDC Crossover Matching brand name "Severe Cold and Flu Relief" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0363-4150	Severe Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
11822-0763	severe cold and flu relief	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
11822-0805	severe cold and flu relief	acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
11822-0895	Severe Cold and Flu Relief	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
30142-716	Severe Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, GUAIFENESIN PHENYLEPHRINE HCL
69842-503	Severe Cold and Flu Relief	Severe Cold and Flu Relief
49738-787	Severe Cold and Flu Relief	Severe Cold and Flu Relief
0280-0921	Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-986	Cold and Flu Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-524	DayQuil Severe plus Vicks VapoCool	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
36800-474	Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-298	Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-697	Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-764	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-775	Pressure Plus Pain PE Plus Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
15127-184	Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-810	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
0363-8591	Walgreens Severe Cold Multi-Symptom For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride