severe cold head congestion

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler: marc glassman, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name severe cold head congestion
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Labeler marc glassman, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Marc Glassman, Inc.

Identifiers & Regulatory

Product NDC 68998-175
Product ID 68998-175_7cebf003-9b2e-f398-e053-2a91aa0a62c2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

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 68998175
Hyphenated Format 68998-175

Supplemental Identifiers

RxCUI
1243679
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 severe cold head congestion (source: ndc)
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number part341 (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 (68998-175-02) / 12 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

68998-175-02 2 BLISTER PACK in 1 CARTON (68998-175-02) / 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)

Severe Cold Head Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7cebf003-9b2e-f398-e053-2a91aa0a62c2", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["3a774544-1994-4a93-9da9-06e55b1a83c8"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Marc Glassman, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68998-175-02)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "68998-175-02", "marketing_start_date": "20150401"}], "brand_name": "Severe Cold Head Congestion", "product_id": "68998-175_7cebf003-9b2e-f398-e053-2a91aa0a62c2", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "68998-175", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Marc Glassman, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Cold Head Congestion", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}