XL-3 Night 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 Night Time
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE
Manufacturer: Rnv LLC
Product type: HUMAN OTC DRUG
SPL set ID: 03210929-331e-462d-b566-4e1865f52246
SPL ID: 49634dc2-a45b-f42b-e063-6294a90ade9c
Version: 3
Effective date: 2026-01-27
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:14:53

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 Night Time	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	openfda.generic_name
manufacturer name		Rnv LLC	openfda.manufacturer_name
ndc	package	84379-444-12	openfda.package_ndc
ndc	package	84379-444-06	openfda.package_ndc
ndc	product	84379-444	openfda.product_ndc
ndc11	package	84379044412	derived:openfda.package_ndc
ndc11	package	84379044406	derived:openfda.package_ndc
rxcui		1043400	openfda.rxcui
spl id		49634dc2-a45b-f42b-e063-6294a90ade9c	id
spl set id		03210929-331e-462d-b566-4e1865f52246	set_id
unii		9D2RTI9KYH	openfda.unii
unii		V9BI9B5YI2	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 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 sever skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is sever, persist for more than two 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.