XL-3 Day Time

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: XL-3 Day Time
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
Manufacturer: Rnv LLC
Product type: HUMAN OTC DRUG
SPL set ID: 2381ff41-4584-4b38-839f-f94e733f5bf2
SPL ID: 49635108-cf29-a6d3-e063-6394a90a9df0
Version: 3
Effective date: 2026-01-27
Source export date: 2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:48:11

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		XL-3 Day Time	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Rnv LLC	openfda.manufacturer_name
ndc	package	84379-441-12	openfda.package_ndc
ndc	package	84379-441-06	openfda.package_ndc
ndc	product	84379-441	openfda.product_ndc
ndc11	package	84379044106	derived:openfda.package_ndc
ndc11	package	84379044112	derived:openfda.package_ndc
rxcui		1113705	openfda.rxcui
spl id		49635108-cf29-a6d3-e063-6394a90a9df0	id
spl set id		2381ff41-4584-4b38-839f-f94e733f5bf2	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	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. Sever liver damage may occur if adult takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adults has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include: • skin reddening • blisters • ras. If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is sever, lasts 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.