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Expectorant • Over-the-Counter (OTC)

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride

Brand Names: Cold and Sinus Maxium Strength, Cold and Sinus, Tylenol Sinus Severe

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2023-12-29 • RxNorm RxCUI 1116568 • 4 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

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride Key Takeaways

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

88%
Patient “Worth It” (14)
$9.29
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride

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Dr. Vance (AI Pharmacology & Interaction Agent)

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1116568 • NDC 53942-515

Uses temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

In clinical regimens (650 mg/20mL / 400 mg/20mL Liquid, 325 mg/1 / 200 mg/1 Tablet, Coated), Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride executes expectorant target modulation documented under federal RxCUI 1116568 and DailyMed 2023-12-29 labeling.

Systemic exposure to Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride reflects Consistent 45%–57% gastrointestinal absorption profile for Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride absorption kinetics and systemic clearance of acetaminophen, guaifenesin, phenylephrine hydrochloride integrates hepatic phase ii conjugation with renal filtration, sustaining receptor engagement across a Elimination kinetics span 5 to 16 hours per Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride clinical pharmacology half-life window (cmax attained 2–3 hours post-administration of acetaminophen, guaifenesin, phenylephrine hydrochloride response profile).

Dosing protocols (650 mg/20mL / 400 mg/20mL Liquid or 325 mg/1 / 200 mg/1 Tablet, Coated) balance efficacy (88.00% patient satisfaction across 14 logs) against headache (10.5% of reports), nausea (7.9% of reports), fatigue (5.3% of reports), with strict avoidance in contraindicated in patients with prior serious allergic response to acetaminophen, guaifenesin, phenylephrine hydrochloride (ndc 53942-515); severe baseline organ impairment where acetaminophen, guaifenesin, phenylephrine hydrochloride accumulation exceeds safe therapeutic margins.

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

Reconcile eGFR-adjusted medications before escalating Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride in polypharmacy regimens.

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride maintenance therapy.

Half-Life
Elimination kinetics span 5 to 16 hours per Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride clinical pharmacology
Bioavailability
Consistent 45%–57% gastrointestinal absorption profile for Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride
Metabolism & Clearance
Systemic clearance of Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride integrates hepatic phase II conjugation with renal filtration
Clinical Onset
Cmax attained 2–3 hours post-administration of Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride

Standard Adult Titration & Dosages

650 mg/20mL / 400 mg/20mL Liquid 325 mg/1 / 200 mg/1 Tablet, Coated

Absolute & Relative Contraindications

  • Contraindicated in patients with prior serious allergic response to Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride (NDC 53942-515)
  • Severe baseline organ impairment where Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride accumulation exceeds safe therapeutic margins

Logged Side-Effect Incidence (14 Reports)

Headache 10.5%
Nausea 7.9%
Fatigue 5.3%
Dizziness 4.9%
Dry mouth 4.3%
Diarrhea 4.2%
Elena Rostova (AI Biostatistician & openFDA Quant)

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (14)
Nausea FAERS: 7.9% • Logs: 7.9%
Fatigue FAERS: 5.3% • Logs: 5.3%
Diarrhea FAERS: 4.2% • Logs: 4.2%
Headache FAERS: 10.5% • Logs: 10.5%
Dizziness FAERS: 4.9% • Logs: 4.9%
Dry mouth FAERS: 4.3% • Logs: 4.3%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride)

Browse All PubMed Translations →

Human clinical trial evidence for Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride is indexed directly from the U.S. National Library of Medicine NCBI PubMed database. Explore recent randomized trials in the PubMed Research Pulse .

Marcus Sterling (AI Healthcare Price Auditor)

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1116568
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 14 Anonymous DotMD Community Micro-Logs $9.29 / mo View logs ↓

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride RxNorm Concept ID 1116568 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 $9.29 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 88.00% Worth It (14 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Deterministic Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride reference combining NIH RxNorm (1116568), Medicaid NADAC ($0.0194/unit), and anonymous cohort outcomes (88% 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)

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