NDC 46084-101

ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED

Acetaminophen, Phenylephrine Hydrochloride

ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by A P J Laboratories Limited. The primary component is Acetaminophen; Phenylephrine Hydrochloride.

• Product ID: 46084-101_529b0e8e-4f74-4d96-b9dc-c57ba66162d3
• NDC: 46084-101
• Product Type: Human Otc Drug
• Proprietary Name: ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED
• Generic Name: Acetaminophen, Phenylephrine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-06-06
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: A P J Laboratories Limited
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 46084-101-30

30 TABLET in 1 BLISTER PACK (46084-101-30)

• Marketing Start Date: 2013-06-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46084-101-30 [46084010130]

ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-06-06
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 44a25c50-b16b-407c-99ea-668afca25924
• Manufacturer:
  • A P J Laboratories Limited
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1046378

NDC Crossover Matching brand name "ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED" or generic name "Acetaminophen, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
46084-101	ACETAMINOPHEN SINUS CONGESTION AND PAIN	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-001	Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-002	Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-158	Medi First Plus Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-146	Medi First Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-148	Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-509	Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
37808-466	Sinus Congestion and Pain	Acetaminophen, Phenylephrine Hydrochloride