NIGHTTIME 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
NIGHTTIME COLD AND FLU
Generic name
ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND DEXTROMETHORPHAN HBR
Manufacturer
BI-MART
Product type
HUMAN OTC DRUG
SPL set ID
36aa5df7-8722-4b80-aa04-d869bc944311
SPL ID
3590d417-272f-ae4d-e063-6394a90a5dc6
Version
1
Effective date
2025-05-01
Source export date
2026-10-30
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-30/7f38ccf216257b076837276c278194f298b4ccda641215a8f83814b33a860b51/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 20:02:13
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product • 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 mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.