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: AptaPharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 94e02be4-b8a6-422a-8f66-e6a69e924b2c
SPL ID: 2fc9865d-66d5-4fb0-9ea8-82f5981b6562
Version: 5
Effective date: 2023-12-30
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:45:30

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 · 16 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		AptaPharma Inc.	openfda.manufacturer_name
ndc	package	76281-304-28	openfda.package_ndc
ndc	package	76281-306-25	openfda.package_ndc
ndc	product	76281-306	openfda.product_ndc
ndc	product	76281-304	openfda.product_ndc
ndc11	package	76281030428	derived:openfda.package_ndc
ndc11	package	76281030625	derived:openfda.package_ndc
rxcui		1113705	openfda.rxcui
spl id		2fc9865d-66d5-4fb0-9ea8-82f5981b6562	id
spl set id		94e02be4-b8a6-422a-8f66-e6a69e924b2c	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. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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. Sore throat warning: If sore throat is severe, 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.