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Histamine-1 Receptor Antagonist • Over-the-Counter (OTC)

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl)

Brand Names: Night Time Severe Cold and Cough Relief

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2024-12-29 • RxNorm RxCUI 1298348 • 9 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

90%
Patient “Worth It” (6)
$9.90
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1298348 • NDC 68016-154

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) represents a over-the-counter branded histamine-1 receptor antagonist entry registered by Chain Drug Consortium, LLC with package codes 68016-154, 0363-9130. Reviewed against 2024-12-29 FDA SPL standards (650 mg/20mL / 25 mg/20mL Liquid; 325 mg/15mL / 12.5 mg/15mL Liquid), clinical deployment addresses Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal and sinus.

Night Time Severe Cold and Cough Relief achieves therapeutic action via Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl, engaging histamine-1 receptor antagonist physiological pathways with class-characteristic hepatorenal disposition. Manufactured in 650 mg/20mL / 25 mg/20mL Liquid; 325 mg/15mL / 12.5 mg/15mL Liquid (registered by Chain Drug Consortium, LLC, NDC 68016-154, 0363-9130), pharmacists evaluate FDA Orange Book therapeutic equivalence when comparing branded Night Time Severe Cold and Cough Relief ($34.50 retail) with generic Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl ($9.90 low cash).

Pharmacokinetic profiling of Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) demonstrates an elimination half-life of Mean elimination half-life of 7 to 18 hours across adult Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) dosing with Oral fraction absorbed ranges from 75% to 87% (Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) 650) systemic bioavailability; clearance proceeds via dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of night time severe cold and cough relief (acetaminophen, diphenhydramine hcl, phenylephrine hcl), reaching clinical onset within oral tmax achieved within 2 to 4 hours following night time severe cold and cough relief (acetaminophen, diphenhydramine hcl, phenylephrine hcl) ingestion.

Titration schedules for Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) (650 mg/20mL / 25 mg/20mL Liquid → 325 mg/15mL / 12.5 mg/15mL Liquid → 325 mg/1 / 25 mg/1 Tablet, Film Coated → 650 mg/30mL / 25 mg/30mL Liquid → 650 mg/237mL / 25 mg/237mL Powder, for Solution) require excluding contraindicated in patients with prior serious allergic response to night time severe cold and cough relief (acetaminophen, diphenhydramine hcl, phenylephrine hcl) (ndc 68016-154); severe baseline organ impairment where acetaminophen, diphenhydramine hcl, phenylephrine hcl accumulation exceeds safe therapeutic margins; real-world patient logs highlight headache (8.9% of reports), nausea (8.5% of reports), dizziness (6.7% of reports) alongside a 90.00% Worth-It consensus.

Key Monitored Interactions:
Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) in polypharmacy regimens.

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) maintenance therapy.

Half-Life
Mean elimination half-life of 7 to 18 hours across adult Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) dosing
Bioavailability
Oral fraction absorbed ranges from 75% to 87% (Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) 650)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl)
Clinical Onset
Oral Tmax achieved within 2 to 4 hours following Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) ingestion

Standard Adult Titration & Dosages

650 mg/20mL / 25 mg/20mL Liquid 325 mg/15mL / 12.5 mg/15mL Liquid 325 mg/1 / 25 mg/1 Tablet, Film Coated 650 mg/30mL / 25 mg/30mL Liquid 650 mg/237mL / 25 mg/237mL Powder, for Solution

Absolute & Relative Contraindications

  • Contraindicated in patients with prior serious allergic response to Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) (NDC 68016-154)
  • Severe baseline organ impairment where Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl accumulation exceeds safe therapeutic margins

Logged Side-Effect Incidence (6 Reports)

Headache 8.9%
Nausea 8.5%
Dizziness 6.7%
Cough 5.9%
Fatigue 5.1%
Application-site irritation 5%
Elena Rostova (AI Biostatistician & openFDA Quant)

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (6)
Cough FAERS: 5.9% • Logs: 5.9%
Nausea FAERS: 8.5% • Logs: 8.5%
Fatigue FAERS: 5.1% • Logs: 5.1%
Headache FAERS: 8.9% • Logs: 8.9%
Dizziness FAERS: 6.7% • Logs: 6.7%
Application-site irritation FAERS: 5% • Logs: 5%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl))

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due: What a 952-Participant Study Found

Pooled data confirm the safety and tolerability of fezolinetant over 52 weeks.

Advances in therapy • 2025-02-15 • Meta-Analysis
N = 952 97/100 PMID 39739195 ↗
New Insights on Evaluating the real-world benefits and safety of SpikoGen®, an: What a 4,219-Participant Study Found

12 657 and 4219 participants were randomized to the SpikoGen® and placebo group and followed for a median of 55 days (interquartile range, 48-60 days) and 51 days.

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases • 2023-02-15 • Phase III Randomized Trial
N = 4,219 96/100 PMID 36096430 ↗
Check Your Medicine Cabinet: Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Pr

October 24, 2026, Tonight We Ride, LLC of Lakeville, Minnesota is voluntarily recalling all lots of Ultimate Forza Male Supplement capsules to the consumer level because it has been found to contain undeclared Sildenafil, Tadalafil, and Dapoxetine.

FDA Drug Recalls • 2026-10-24 • FDA Recall
Multi-cohort 95/100 PMID FDA_RECALLS-743098658 ↗
New Insights on Baricitinib Withdrawal and Retreatment in Patients With Severe hair loss Areata:: What a 654-Participant Study Found

Of 654 patients who received treatment, the mean (SD) age was 37.1 (13.0) years, and there were 383 women (58.6%).

JAMA dermatology • 2024-10-01 • Phase III Randomized Trial
N = 654 93/100 PMID 39141364 ↗
New Insights on SLE-DAS enables an accurate definition of severe lupus disease activity:: What a 438-Participant Study Found

The SLE-DAS cut-off for SDA provides an accurate definition of SDA in SLE, with good discriminative power and consistent associations with worse HR-QoL.

Lupus science & medicine • 2025-05-16 • Phase III Randomized Trial
N = 438 93/100 PMID 40379439 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1298348
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.0194/unit (~$0.58/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $34.50 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 6 Anonymous DotMD Community Micro-Logs $9.90 / mo View logs ↓

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) RxNorm Concept ID 1298348 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.0194 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $34.50 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $9.90 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 90.00% Worth It (6 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) Patient Community, Cohort Filters & Dosage Logs

Cross-verified Night Time Severe Cold and Cough Relief (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl) (histamine-1 receptor antagonist) monograph synthesizing RxNorm 1298348, openFDA FAERS signals, and $9.90–$34.50 cash benchmarks.

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