FDA.reportPublic FDA data

Daytime Cold and Flu Relief

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
Daytime Cold and Flu Relief
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
Manufacturer
SALADO SALES INC.
Product type
HUMAN OTC DRUG
SPL set ID
8f66f5bc-7c77-420b-9feb-911c980fbfdc
SPL ID
5d9c0ef9-7ee4-4630-b962-d3cd720ae282
Version
1
Effective date
2025-12-12
Source export date
2026-08-17
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/2026-08-17/1428ecb25c316753060ea7ddb566e8693893fa6e325c185f8717828825c2afb3/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 08:43:14
Harmonized routes table
Harmonized routes
ORAL

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 8 liquid caps 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.