severe sinus congestion and pain maximum strength

Generic: acetaminophen, guaifenesin, phenylephrine hcl

Labeler: better living brands, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe sinus congestion and pain maximum strength
Generic Name acetaminophen, guaifenesin, phenylephrine hcl
Labeler better living brands, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Better Living Brands, LLC

Identifiers & Regulatory

Product NDC 21130-615
Product ID 21130-615_84f69757-d93a-4844-9ce7-85498d1ca623
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-06-30

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 21130615
Hyphenated Format 21130-615

Supplemental Identifiers

RxCUI
1243679
UPC
0321130763857
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 sinus congestion and pain maximum strength (source: ndc)
Generic Name acetaminophen, guaifenesin, phenylephrine hcl (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 (21130-615-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

21130-615-09 2 BLISTER PACK in 1 CARTON (21130-615-09) / 10 TABLET, FILM 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 Sinus Congestion and Pain Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "84f69757-d93a-4844-9ce7-85498d1ca623", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0321130763857"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["b7b1c3cc-fdf3-4e75-8c3f-2e832f09a887"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Better Living Brands, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (21130-615-09)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "21130-615-09", "marketing_start_date": "20130630"}], "brand_name": "Severe Sinus Congestion and Pain Maximum Strength", "product_id": "21130-615_84f69757-d93a-4844-9ce7-85498d1ca623", "dosage_form": "TABLET, FILM 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": "21130-615", "generic_name": "Acetaminophen, Guaifenesin, Phenylephrine HCl", "labeler_name": "Better Living Brands, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Sinus Congestion and Pain", "brand_name_suffix": "Maximum Strength", "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": "20130630", "listing_expiration_date": "20261231"}