Severe sinus Congestion Relief

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Severe sinus Congestion Relief
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: FOODHOLD U.S.A., LLC
Product type: HUMAN OTC DRUG
SPL set ID: e173bec9-14df-4535-a023-47d8cda8d4ec
SPL ID: 2778c533-445e-a395-e063-6394a90a51a3
Version: 3
Effective date: 2024-11-21
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:33

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Severe sinus Congestion Relief	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		FOODHOLD U.S.A., LLC	openfda.manufacturer_name
ndc	package	41520-985-14	openfda.package_ndc
ndc	product	41520-985	openfda.product_ndc
ndc11	package	41520098514	derived:openfda.package_ndc
rxcui		1656815	openfda.rxcui
spl id		2778c533-445e-a395-e063-6394a90a51a3	id
spl set id		e173bec9-14df-4535-a023-47d8cda8d4ec	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		362O9ITL9D	openfda.unii
unii		495W7451VQ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 liquid gels in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.