Cold Medicine XL3

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 Medicine XL3
Generic name: ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE
Manufacturer: Selder, S.A. de C.V.
Product type: HUMAN OTC DRUG
SPL set ID: e2c35fae-9dd6-51f2-e053-2995a90a1e9e
SPL ID: 24b20246-5fa0-1d44-e063-6394a90a625d
Version: 2
Effective date: 2024-10-17
Source export date: 2026-11-06
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/f699a9578a0c5d6f5abd59491e85ce3c2c5e4567a51003fee350566c56ba5812/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:30:39

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 Medicine XL3	openfda.brand_name
generic name		ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Selder, S.A. de C.V.	openfda.manufacturer_name
ndc	package	63654-605-20	openfda.package_ndc
ndc	product	63654-605	openfda.product_ndc
ndc11	package	63654060520	derived:openfda.package_ndc
rxcui		1046781	openfda.rxcui
spl id		24b20246-5fa0-1d44-e063-6394a90a625d	id
spl set id		e2c35fae-9dd6-51f2-e053-2995a90a1e9e	set_id
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 Alergy 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.