Cough and Cold XL3 Xtra

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: Cough and Cold XL3 Xtra
Generic name: ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE
Manufacturer: Selder, S.A. de C.V.
Product type: HUMAN OTC DRUG
SPL set ID: da5b31dd-becd-471a-9392-d0ee4b8f9539
SPL ID: 24b2193a-79ff-3792-e063-6394a90ad104
Version: 6
Effective date: 2024-10-17
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:20:03

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Cough and Cold XL3 Xtra	openfda.brand_name
generic name		ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Selder, S.A. de C.V.	openfda.manufacturer_name
ndc	package	63654-800-06	openfda.package_ndc
ndc	package	63654-800-12	openfda.package_ndc
ndc	package	63654-800-20	openfda.package_ndc
ndc	product	63654-800	openfda.product_ndc
ndc11	package	63654080020	derived:openfda.package_ndc
ndc11	package	63654080012	derived:openfda.package_ndc
ndc11	package	63654080006	derived:openfda.package_ndc
rxcui		1193292	openfda.rxcui
spl id		24b2193a-79ff-3792-e063-6394a90ad104	id
spl set id		da5b31dd-becd-471a-9392-d0ee4b8f9539	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		V1Q0O9OJ9Z	openfda.unii
unii		362O9ITL9D	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 tablets in 24 hours, which is the maximum daily amount • 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.