tylenol sinus severe

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler: navajo manufacturing company inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tylenol sinus severe
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Labeler navajo manufacturing company inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Navajo Manufacturing Company Inc.

Identifiers & Regulatory

Product NDC 67751-239
Product ID 67751-239_435b5b96-73d0-4d01-e063-6394a90ae4dd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-02-19

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67751239
Hyphenated Format 67751-239

Supplemental Identifiers

RxCUI
1243679
UNII
362O9ITL9D 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tylenol sinus severe (source: ndc)
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (67751-239-01) / 2 TABLET, COATED in 1 POUCH
  • 2 POUCH in 1 CARTON (67751-239-02) / 2 TABLET, COATED in 1 POUCH
source: ndc

Packages (2)

67751-239-01 1 POUCH in 1 CARTON (67751-239-01) / 2 TABLET, COATED in 1 POUCH 67751-239-02 2 POUCH in 1 CARTON (67751-239-02) / 2 TABLET, COATED in 1 POUCH

Ingredients (3)

acetaminophen (325 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Tylenol Sinus Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "435b5b96-73d0-4d01-e063-6394a90ae4dd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["435b4a2a-d6bf-ec25-e063-6294a90a3f06"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Navajo Manufacturing Company Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (67751-239-01)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "67751-239-01", "marketing_start_date": "20250219"}, {"sample": false, "description": "2 POUCH in 1 CARTON (67751-239-02)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "67751-239-02", "marketing_start_date": "20250219"}], "brand_name": "Tylenol Sinus Severe", "product_id": "67751-239_435b5b96-73d0-4d01-e063-6394a90ae4dd", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "67751-239", "generic_name": "Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Navajo Manufacturing Company Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol Sinus Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250219", "listing_expiration_date": "20261231"}