Nuvicare DayTime Cold and Flu Softgel

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: Nuvicare DayTime Cold and Flu Softgel
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: NUVICARE LLC
Product type: HUMAN OTC DRUG
SPL set ID: bdc35570-c8df-4797-a13e-7f2479ec42b7
SPL ID: 6b80519a-1e97-464a-b7ce-baa26ede64db
Version: 1
Effective date: 2025-06-09
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:09:59

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		Nuvicare DayTime Cold and Flu Softgel	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		NUVICARE LLC	openfda.manufacturer_name
ndc	package	84324-023-01	openfda.package_ndc
ndc	product	84324-023	openfda.product_ndc
ndc11	package	84324002301	derived:openfda.package_ndc
rxcui		1086997	openfda.rxcui
spl id		6b80519a-1e97-464a-b7ce-baa26ede64db	id
spl set id		bdc35570-c8df-4797-a13e-7f2479ec42b7	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

Warning Allergy Alert: acetamenophen may cause severe skin recations. Symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin reactions occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product. Sore throat warning: If sore throat is severe, persists 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.