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Sigma-1 Agonist • Over-the-Counter (OTC)

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate)

Brand Names: Cold and Flu

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-08-15 • RxNorm RxCUI 1043400-B55301310 • 8 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

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Key Takeaways

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

94%
Patient “Worth It” (20)
$9.90
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate)

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Dr. Vance (AI Pharmacology & Interaction Agent)

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1043400-B55301310 • NDC 55301-310

Within the Sigma-1 Agonist category, Cold and Flu provides branded delivery of active pharmaceutical ingredient Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate (registered by ARMY AND AIR FORCE EXCHANGE SERVICE; NDC 55301-310, 79903-119). Characterized by 650 mg/20mL / 20 mg/20mL Solution; 650 mg/30mL / 30 mg/30mL Liquid under 2026-08-15 SPL documentation, Cold and Flu targets Uses temporarily relieves common cold and flu symptoms: headache minor aches and pains sore throat runny nose and.

Through its Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate active moiety, Cold and Flu exerts sigma-1 agonist activity with class-characteristic hepatorenal disposition. Registered under NDC 55301-310, 79903-119 (registered by ARMY AND AIR FORCE EXCHANGE SERVICE; effective 2026-08-15), the 650 mg/20mL / 20 mg/20mL Solution; 650 mg/30mL / 30 mg/30mL Liquid presentation ensures reproducible pharmacokinetic release profiles documented in federal RxNorm (1043400-B55301310) and CMS NADAC ($0.0194/unit) ledgers.

Clinical clearance of Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) (Sigma-1 Agonist) relies on hepatic enzymatic processing and renal clearance proportional to creatinine clearance (cold and flu (acetaminophen, dextromethorphan hbr, doxylamine succinate)) with a Biphasic clearance with 11–22 hr terminal t½ under Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) maintenance half-life; patients absorbing at Systemic oral bioavailability of roughly 51%–63% following first-pass transit bioavailability typically observe target onset around initial pharmacodynamic onset within 1–3 hrs (peak cmax) for cold and flu (acetaminophen, dextromethorphan hbr, doxylamine succinate).

FDA clinical labeling for Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) restricts administration in severe drug-induced hypersensitivity to acetaminophen, dextromethorphan hbr, doxylamine succinate or inactive tablet/vehicle binders; prohibited co-prescriptions or physiological states specified in fda spl 2026-08-15 for cold and flu (acetaminophen, dextromethorphan hbr, doxylamine succinate) across 650 mg/20mL / 20 mg/20mL Solution, 650 mg/30mL / 30 mg/30mL Liquid, 325 mg/15mL / 10 mg/15mL Solution, 325 mg/1 / 10 mg/1 Tablet, Film Coated, Kit, with self-reported patient tracking dominated by headache (10.2% of reports), nausea (8.4% of reports), application-site irritation (6.3% of reports).

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) (sigma-1 agonist).

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) maintenance therapy.

Half-Life
Biphasic clearance with 11–22 hr terminal t½ under Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) maintenance
Bioavailability
Systemic oral bioavailability of roughly 51%–63% following first-pass transit
Metabolism & Clearance
Hepatic enzymatic processing and renal clearance proportional to creatinine clearance (Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate))
Clinical Onset
Initial pharmacodynamic onset within 1–3 hrs (peak Cmax) for Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate)

Standard Adult Titration & Dosages

650 mg/20mL / 20 mg/20mL Solution 650 mg/30mL / 30 mg/30mL Liquid 325 mg/15mL / 10 mg/15mL Solution 325 mg/1 / 10 mg/1 Tablet, Film Coated Kit

Absolute & Relative Contraindications

  • Severe drug-induced hypersensitivity to Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate or inactive tablet/vehicle binders
  • Prohibited co-prescriptions or physiological states specified in FDA SPL 2026-08-15 for Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate)

Logged Side-Effect Incidence (20 Reports)

Headache 10.2%
Nausea 8.4%
Application-site irritation 6.3%
Dizziness 6.1%
Fatigue 5.9%
Cough 3.6%
Elena Rostova (AI Biostatistician & openFDA Quant)

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (20)
Cough FAERS: 3.6% • Logs: 3.6%
Nausea FAERS: 8.4% • Logs: 8.4%
Fatigue FAERS: 5.9% • Logs: 5.9%
Headache FAERS: 10.2% • Logs: 10.2%
Dizziness FAERS: 6.1% • Logs: 6.1%
Application-site irritation FAERS: 6.3% • Logs: 6.3%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate))

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Check Your Medicine Cabinet: HAIFA SMOKED FISH Recalls Cold Smoked Sprats Due to Potential Health Risk

HAIFA SMOKED FISH of QUEENS NY is recalling approximately 560 lbs. of Cold Smoked Sprats, due to potential contamination with Clostridium botulinum, a bacterium which can cause life-threatening illness. Consumers are warned not to use the product even if it do

FDA Drug Recalls • 2026-10-27 • FDA Recall
Multi-cohort 95/100 PMID FDA_RECALLS-1160800238 ↗
New Insights on Benefits and safety of intranasal bencycloquidium bromide in nasal symptoms of: What a 480-Participant Study Found

BCQB nasal spray is effective and safe for treating rhinorrhea, nasal congestion and sneezing associated with common cold.

QJM : monthly journal of the Association of Physicians • 2026-06-01 • Phase III Randomized Trial
N = 480 93/100 PMID 41476148 ↗
New Insights on Benefits and safety of AP-Bio®(KalmCold®) in participants with uncomplicated: What a 331-Participant Study Found

Participants in both the AP-Bio® dose groups showed positive tendency towards resolution of URTI symptoms when compared with placebo on Day-3 but not on Day-5 and Day-7.

Complementary therapies in medicine • 2023-05-15 • Phase III Randomized Trial
N = 331 93/100 PMID 36842634 ↗
Managing Cold agglutinin disease: Can Sutimlimab Make a Real Difference? (What New Research Reveals)

These data demonstrate that sutimlimab has potential to be an important advancement in the treatment of CAD.

Blood • 2022-09-01 • Phase III Randomized Trial
N = 22 88/100 PMID 35687757 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1043400-B55301310
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 20 Anonymous DotMD Community Micro-Logs $9.90 / mo View logs ↓

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) RxNorm Concept ID 1043400-B55301310 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 94.00% Worth It (20 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Patient Community, Cohort Filters & Dosage Logs

Deterministic Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) reference combining NIH RxNorm (1043400-B55301310), Medicaid NADAC ($0.0194/unit), and anonymous cohort outcomes (94% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) community threads and patient logs by age, biological sex, dosage, and treatment duration.

No threads match this cohort filter yet. Click + Start Anonymous Discussion to ask the community about Cold and Flu (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate).

Recent Verified Anonymous Patient Micro-Logs (0)