Severe Sinus Congestion and Pain

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 and Pain
Generic name: ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE
Manufacturer: Shield Pharmaceuticals Corp
Product type: HUMAN OTC DRUG
SPL set ID: c296efd0-5030-4a26-a9b0-e66423d995dc
SPL ID: 4276cd88-1e20-408b-e063-6394a90ae904
Version: 4
Effective date: 2025-10-31
Source export date: 2026-10-30
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:58:43

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Severe Sinus Congestion and Pain	openfda.brand_name
generic name		ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	openfda.generic_name
manufacturer name		Shield Pharmaceuticals Corp	openfda.manufacturer_name
ndc	package	83059-0057-1	openfda.package_ndc
ndc	product	83059-0057	openfda.product_ndc
ndc11	package	83059005701	derived:openfda.package_ndc
rxcui		1243679	openfda.rxcui
spl id		4276cd88-1e20-408b-e063-6394a90ae904	id
spl set id		c296efd0-5030-4a26-a9b0-e66423d995dc	set_id
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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day 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.