NDC 41520-783

CareOne Cold and Sinus

Acetaminophen, Guaifenesin, Phenylephrine Hcl

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

• Product ID: 41520-783_e8e4f637-45d7-48df-9f5e-b7cce28050b3
• NDC: 41520-783
• Product Type: Human Otc Drug
• Proprietary Name: CareOne Cold and Sinus
• Generic Name: Acetaminophen, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-05
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: American Sales Company
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 41520-783-01

10 BLISTER PACK in 1 CARTON (41520-783-01) > 2 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2016-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 41520-783-01 [41520078301]

CareOne Cold and Sinus TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-08-05

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 39fa9c83-5995-4e90-a9b4-5ba668068fec
• Manufacturer:
  • American Sales Company
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679

NDC Crossover Matching brand name "CareOne Cold and Sinus" or generic name "Acetaminophen, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
41520-783	CareOne Cold and Sinus	CareOne Cold and Sinus
41520-831	CareOne Cold and Sinus	CareOne Cold and Sinus
0363-9527	Cold and Head Congestion	Acetaminophen, Guaifenesin, Phenylephrine HCl
0113-0145	Good Sense Mucus Relief	Acetaminophen, guaifenesin, phenylephrine HCl
0363-0628	Mucus Relief	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-3350	Mucus Relief	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-0156	Mucus Relief Severe Sinus Congestion	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-4120	Pressure plus Pain plus Mucus	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-5027	Severe Sinus	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-6150	Severe Sinus Congestion	Acetaminophen, Guaifenesin, Phenylephrine HCl
11822-5160	severe sinus congestion relief	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-6028	Sinus Pressure and Pain	Acetaminophen, Guaifenesin, Phenylephrine HCl
11673-628	Sinus Pressure and Pain Relief	acetaminophen, guaifenesin, phenylephrine HCl
0363-0478	Sinus Relief Severe Congestion	Acetaminophen, Guaifenesin, Phenylephrine HCl
11673-927	Sinus Severe	Acetaminophen, Guaifenesin, Phenylephrine HCl
0363-4121	Wal-Phed HEAD CONGESTION AND MUCUS	Acetaminophen, Guaifenesin, Phenylephrine HCl