Cold and Sinus Maxium Strength

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: Cold and Sinus Maxium Strength
Generic name: ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: DeMoulas Market Basket
Product type: HUMAN OTC DRUG
SPL set ID: 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc
SPL ID: b2c93822-291f-4839-a6fd-9b515a8965a9
Version: 2
Effective date: 2023-12-29
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:30:58

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		Cold and Sinus Maxium Strength	openfda.brand_name
generic name		ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		DeMoulas Market Basket	openfda.manufacturer_name
ndc	package	53942-515-25	openfda.package_ndc
ndc	product	53942-515	openfda.product_ndc
ndc11	package	53942051525	derived:openfda.package_ndc
rxcui		1116568	openfda.rxcui
spl id		b2c93822-291f-4839-a6fd-9b515a8965a9	id
spl set id		6e5ca8e1-5a03-4e77-b385-d44387fb3bfc	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 acetamnophen. 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. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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