nasal decongestant pe and pain relief plus mucus relief

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler: winco foods, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nasal decongestant pe and pain relief plus mucus relief
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Labeler winco foods, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Winco Foods, LLC

Identifiers & Regulatory

Product NDC 67091-349
Product ID 67091-349_2860d8a0-4862-9d45-e063-6294a90af22e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-10-25

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 67091349
Hyphenated Format 67091-349

Supplemental Identifiers

RxCUI
1243679
UPC
0070552250680
UNII
362O9ITL9D 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

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 nasal decongestant pe and pain relief plus mucus relief (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
  • 2 BLISTER PACK in 1 CARTON (67091-349-24) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

67091-349-24 2 BLISTER PACK in 1 CARTON (67091-349-24) / 12 TABLET, COATED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Nasal Decongestant PE and Pain Relief Plus Mucus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2860d8a0-4862-9d45-e063-6294a90af22e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0070552250680"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["31531f90-8933-46ab-b722-cb63e7738639"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Winco Foods, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (67091-349-24)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "67091-349-24", "marketing_start_date": "20171025"}], "brand_name": "Nasal Decongestant PE and Pain Relief Plus Mucus Relief", "product_id": "67091-349_2860d8a0-4862-9d45-e063-6294a90af22e", "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": "67091-349", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Winco Foods, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nasal Decongestant PE and Pain Relief Plus Mucus Relief", "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": "20171025", "listing_expiration_date": "20261231"}