NDC 63561-0129

FLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula

Acetaminophen, Dextromethorphan, Phenylephrine

FLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Granulation Technology, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 63561-0129_64a23776-4a40-0670-e053-2991aa0a656b
• NDC: 63561-0129
• Product Type: Human Otc Drug
• Proprietary Name: FLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula
• Generic Name: Acetaminophen, Dextromethorphan, Phenylephrine
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GRANULATION TECHNOLOGY, INC.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63561-0129-6

6 PACKET in 1 CARTON (63561-0129-6) > 1 POWDER, FOR SOLUTION in 1 PACKET

• Marketing Start Date: 2018-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63561-0129-6 [63561012906]

FLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula POWDER, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-03-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/1

OpenFDA Data

• SPL SET ID: 7f62773d-e6be-4ec6-8375-59944c28163d
• Manufacturer:
  • GRANULATION TECHNOLOGY, INC.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1659967

NDC Crossover Matching brand name "FLU-MED DAYTIME SEVERE COLD and COUGH non drowsy formula" or generic name "Acetaminophen, Dextromethorphan, Phenylephrine"

NDC	Brand Name	Generic Name
59779-776	CVS Daytime Severe Cough and Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
67510-0544	Day Time Cold/Flu Relief	Acetaminophen, Dextromethorphan, Phenylephrine
59970-077	Day Time Gelcap	Acetaminophen, Dextromethorphan, Phenylephrine
67510-0523	Day Time Gelcap	Acetaminophen, Dextromethorphan, Phenylephrine
69517-102	DayTime Cold and Flu Relief	Acetaminophen, Dextromethorphan, Phenylephrine
63561-1129	end-a-flu	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
63561-0129	FLU-MED	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
63868-290	Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
67091-322	Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
0067-6094	Theraflu	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
0067-7917	Theraflu	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
52904-896	Theraflu Daytime Severe Cold and Cough	acetaminophen, dextromethorphan, phenylephrine