NDC 70005-012

SINUS CONGESTION AND PAIN RELIEF

Acetaminophen, Guaifenesin And Phenylephrine Hcl 325 Mg, 200 Mg And 5 Mg

SINUS CONGESTION AND PAIN RELIEF is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by We Care Distributor Inc.. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 70005-012_1682b725-e5f7-45a1-a8de-11d14be8ca37
• NDC: 70005-012
• Product Type: Human Otc Drug
• Proprietary Name: SINUS CONGESTION AND PAIN RELIEF
• Generic Name: Acetaminophen, Guaifenesin And Phenylephrine Hcl 325 Mg, 200 Mg And 5 Mg
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-02-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: We Care Distributor Inc.
• 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 70005-012-50

50 POUCH in 1 BOX (70005-012-50) > 2 TABLET, COATED in 1 POUCH

• Marketing Start Date: 2016-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70005-012-25 [70005001225]

SINUS CONGESTION AND PAIN RELIEF TABLET, COATED

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-15

NDC 70005-012-50 [70005001250]

SINUS CONGESTION AND PAIN RELIEF TABLET, COATED

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-15

NDC 70005-012-02 [70005001202]

SINUS CONGESTION AND PAIN RELIEF TABLET, COATED

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-15

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 1f6fb7c8-d3f6-4e1f-9da1-4a7d6ea90f1b
• Manufacturer:
  • We Care Distributor Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679

NDC Crossover Matching brand name "SINUS CONGESTION AND PAIN RELIEF" or generic name "Acetaminophen, Guaifenesin And Phenylephrine Hcl 325 Mg, 200 Mg And 5 Mg"

NDC	Brand Name	Generic Name
11822-0527	Sinus Congestion and Pain Relief	Acetaminophen, Guaifenesin and Phenylephrine HCl
11822-0588	Sinus Congestion and Pain Relief	Acetaminophen and Phenylephrine HCl
50804-119	Sinus Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
50844-664	Sinus Congestion and Pain Relief	Acetaminophen and Phenylephrine HCl
67091-213	Sinus Congestion and Pain Relief	Acetaminophen, Phenylephrine HCl
70005-012	SINUS CONGESTION AND PAIN RELIEF	Acetaminophen, Guaifenesin and Phenylephrine HCl 325 mg, 200 mg and 5 mg