severe congestion and sinus relief maximum strength

Generic: acetaminophen, guaifenesin, phenylephrine hcl

Labeler: equate (wal-mart stores, inc.) (see also wal-mart inc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe congestion and sinus relief maximum strength
Generic Name acetaminophen, guaifenesin, phenylephrine hcl
Labeler equate (wal-mart stores, inc.) (see also wal-mart inc)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Identifiers & Regulatory

Product NDC 49035-478
Product ID 49035-478_0423f6ec-9b81-411b-809a-793c79af7336
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-04-30

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 49035478
Hyphenated Format 49035-478

Supplemental Identifiers

RxCUI
1116568
UPC
0681131276702
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 congestion and sinus relief maximum strength (source: ndc)
Generic Name acetaminophen, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 400 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (49035-478-06)
source: ndc

Packages (1)

49035-478-06 177 mL in 1 BOTTLE, PLASTIC (49035-478-06)

Ingredients (3)

acetaminophen (650 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Severe Congestion and Sinus Relief Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0423f6ec-9b81-411b-809a-793c79af7336", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0681131276702"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116568"], "spl_set_id": ["aaccafe6-2e76-4023-a5d8-bcec27f60f08"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49035-478-06)", "package_ndc": "49035-478-06", "marketing_start_date": "20180430"}], "brand_name": "Severe Congestion and Sinus Relief Maximum Strength", "product_id": "49035-478_0423f6ec-9b81-411b-809a-793c79af7336", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "49035-478", "generic_name": "Acetaminophen, Guaifenesin, Phenylephrine HCl", "labeler_name": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Congestion and Sinus Relief", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180430", "listing_expiration_date": "20261231"}