NDC 41520-639

CareOne Cold plus Flu Severe

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

CareOne Cold plus Flu Severe is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by American Sales Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 41520-639_566bf40b-b4f4-4287-a04d-af6ea4593364
• NDC: 41520-639
• Product Type: Human Otc Drug
• Proprietary Name: CareOne Cold plus Flu Severe
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-14
• Marketing End Date: 2021-11-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: American Sales Company
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N

Packaging

NDC 41520-639-62

12 BLISTER PACK in 1 CARTON (41520-639-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2016-09-14
• Marketing End Date: 2021-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 41520-639-62 [41520063962]

CareOne Cold plus Flu Severe TABLET, FILM COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-09-14

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: feebe746-959d-4bb1-9fc5-ba274f0ddd66
• Manufacturer:
  • American Sales Company
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988

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

NDC	Brand Name	Generic Name
41520-639	CareOne Cold plus Flu Severe	CareOne Cold plus Flu Severe
0113-7603	Basic Care Daytime Cold and Flu Severe	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-7303	basic care mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0640	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0299	good sense cold and flu severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0234	good sense cold head congestion	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0381	Good Sense Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-1913	good sense mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0579	good sense severe cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0548	Good Sense Severe Daytime	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0603	Good Sense Severe Daytime Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-9007	Good Sense Severe Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-0616	Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0538	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0719	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0372	Mucus Relief Plus	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0410	Mucus Relief Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0503	Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0524	Sinus Relief	Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
0067-8145	Theraflu ExpressMax Severe Cold and Flu Caplets	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0067-8132	Theraflu ExpressMax Severe Cold and Flu Syrup	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0051	Wal Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl