Xpect Cold 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: Xpect Cold Relief
Generic name: ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL
Manufacturer: Cintas Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 02391d55-32b2-4083-9315-98e9b3650c55
SPL ID: 59bbb82a-0247-417c-b0ed-991646373be8
Version: 10
Effective date: 2026-01-08
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:29:08

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 · 21 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Xpect Cold Relief	openfda.brand_name
generic name		ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Cintas Corporation	openfda.manufacturer_name
ndc	package	42961-112-10	openfda.package_ndc
ndc	package	42961-112-13	openfda.package_ndc
ndc	package	42961-112-12	openfda.package_ndc
ndc	package	42961-112-14	openfda.package_ndc
ndc	package	42961-112-11	openfda.package_ndc
ndc	product	42961-112	openfda.product_ndc
ndc11	package	42961011210	derived:openfda.package_ndc
ndc11	package	42961011214	derived:openfda.package_ndc
ndc11	package	42961011212	derived:openfda.package_ndc
ndc11	package	42961011213	derived:openfda.package_ndc
ndc11	package	42961011211	derived:openfda.package_ndc
rxcui		1243679	openfda.rxcui
spl id		59bbb82a-0247-417c-b0ed-991646373be8	id
spl set id		02391d55-32b2-4083-9315-98e9b3650c55	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. 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: blisters, rash, skin reddening. 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.