Original Night-Time MULTI-SYMPTOM COLD/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
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Manufacturer
Discount Drug Mart
Product type
HUMAN OTC DRUG
SPL set ID
e243033b-6603-4c3e-a330-e7c7de51f69d
SPL ID
46538946-6c44-dce2-e063-6394a90ae990
Version
6
Effective date
2025-12-19
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:51
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

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN Failure to follow these warnings could result in serious consequences. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ● more than 4 doses in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks everyday while using this product. Allery Alert: Acetaminophen may cause severe 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 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.