DAY-TIME Cold and Flu

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: DAY-TIME Cold and Flu
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: DeMoulas Market Basket
Product type: HUMAN OTC DRUG
SPL set ID: ce900e42-d0c8-408d-a1c3-3a9bef1c97ee
SPL ID: ed7f1c85-7869-46c8-9f8f-3ba637f81b6e
Version: 3
Effective date: 2023-12-29
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:24:57

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		M013	openfda.application_number
brand name		DAY-TIME Cold and Flu	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		DeMoulas Market Basket	openfda.manufacturer_name
ndc	package	53942-506-28	openfda.package_ndc
ndc	product	53942-506	openfda.product_ndc
ndc11	package	53942050628	derived:openfda.package_ndc
rxcui		1113705	openfda.rxcui
spl id		ed7f1c85-7869-46c8-9f8f-3ba637f81b6e	id
spl set id		ce900e42-d0c8-408d-a1c3-3a9bef1c97ee	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 you take more than 4 doses 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. Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include: skin reddening blisters rash If a skin reactions occurs, stop and seek medical help right away. 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.