NDC 41520-561

CareOne Nighttime Severe Cold and Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

CareOne Nighttime Severe Cold and Flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by American Sales Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 41520-561_2e88a4ab-3dde-465f-83c6-d6e152c1207e
• NDC: 41520-561
• Product Type: Human Otc Drug
• Proprietary Name: CareOne Nighttime Severe Cold and Flu
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: American Sales Company
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 41520-561-40

355 mL in 1 BOTTLE (41520-561-40)

• Marketing Start Date: 2016-04-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 41520-561-40 [41520056140]

careone nighttime severe cold and flu SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-04-11

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: 819d5c82-0240-4013-9904-c335bd65d03e
• Manufacturer:
  • American Sales Company
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1431245

NDC Crossover Matching brand name "CareOne Nighttime Severe Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
41520-561	CareOne Nighttime Severe Cold and Flu	CareOne Nighttime Severe Cold and Flu
0280-1138	Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0113-7580	basic care daytime nighttime cold and flu	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
0363-1213	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0363-2211	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-2212	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-6596	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-6770	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-1009	Day Time Night Time Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0363-1142	Day Time Night Time Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0363-0567	daytime nighttime cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0363-1733	daytime nighttime cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0113-0567	Good Sense NightTime DayTime Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0113-0019	Good Sense Severe NightTime	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
0113-0763	Good Sense Severe NightTime Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-1031	Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
0363-0331	Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
0363-1011	NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
0363-0623	severe cold and flu	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
0363-0763	Severe Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
0363-1597	Severe Cold and Flu	acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl