ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL

N/A

Manufactured by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

769 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). The most commonly reported adverse reactions for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL include FATIGUE, PNEUMONIA, COVID-19, DIARRHOEA, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL.

Top Adverse Reactions

FATIGUE26 reports
PNEUMONIA19 reports
COVID 1917 reports
DIARRHOEA17 reports
FALL17 reports
DYSPNOEA16 reports
NAUSEA16 reports
PAIN16 reports
PRODUCT DOSE OMISSION ISSUE16 reports
DRUG INEFFECTIVE14 reports
PRURITUS13 reports
ANXIETY12 reports
ASTHENIA12 reports
ASTHMA12 reports
BACK PAIN12 reports
DEATH12 reports
INSOMNIA12 reports
SOMNOLENCE12 reports
VOMITING12 reports
WEIGHT DECREASED12 reports
COUGH11 reports
HEADACHE11 reports
URINARY TRACT INFECTION11 reports
DIZZINESS10 reports
OFF LABEL USE10 reports
ACUTE KIDNEY INJURY9 reports
CHRONIC KIDNEY DISEASE9 reports
HYPERTENSION9 reports
MALAISE9 reports
SINUSITIS9 reports
SURGERY9 reports
ARTHRALGIA8 reports
CONSTIPATION8 reports
INFECTION8 reports
PYREXIA8 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE7 reports
ILLNESS7 reports
OSTEOPOROSIS7 reports
PAIN IN EXTREMITY7 reports
RASH7 reports
ABDOMINAL PAIN UPPER6 reports
ARTHRITIS6 reports
BLOOD PRESSURE INCREASED6 reports
CONDITION AGGRAVATED6 reports
DEHYDRATION6 reports
DEPRESSION6 reports
HAEMOGLOBIN DECREASED6 reports
INJECTION SITE PAIN6 reports
LUNG DISORDER6 reports
OROPHARYNGEAL PAIN6 reports
PRODUCT ADMINISTRATION INTERRUPTED6 reports
PSORIASIS6 reports
RENAL FAILURE6 reports
ROAD TRAFFIC ACCIDENT6 reports
SWELLING6 reports
URTICARIA6 reports
VISUAL IMPAIRMENT6 reports
ANHEDONIA5 reports
CATARACT5 reports
CONTUSION5 reports
CYSTITIS5 reports
DISEASE RECURRENCE5 reports
DRUG HYPERSENSITIVITY5 reports
DRY MOUTH5 reports
DYSPEPSIA5 reports
ERYTHEMA5 reports
FOREIGN BODY IN THROAT5 reports
GAIT DISTURBANCE5 reports
HOSPITALISATION5 reports
HYPOAESTHESIA5 reports
HYPOTENSION5 reports
IMPAIRED QUALITY OF LIFE5 reports
INFLUENZA5 reports
NASAL CONGESTION5 reports
NASOPHARYNGITIS5 reports
PARAESTHESIA5 reports
PERIPHERAL SWELLING5 reports
PRODUCT USE IN UNAPPROVED INDICATION5 reports
RENAL DISORDER5 reports
RENAL TUBULAR ACIDOSIS5 reports
SEIZURE5 reports
THROAT IRRITATION5 reports
THROMBOSIS5 reports
ABDOMINAL DISCOMFORT4 reports
ANTI NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS4 reports
BONE METABOLISM DISORDER4 reports
CARDIAC DISORDER4 reports
CELLULITIS4 reports
CEREBROVASCULAR ACCIDENT4 reports
CHEST PAIN4 reports
DECREASED APPETITE4 reports
DRUG INTERACTION4 reports
ECONOMIC PROBLEM4 reports
EMOTIONAL DISTRESS4 reports
FEELING ABNORMAL4 reports
HALLUCINATION4 reports
HIP FRACTURE4 reports
HYPERHIDROSIS4 reports
INFLAMMATION4 reports
INTENTIONAL DOSE OMISSION4 reports

Report Outcomes

Out of 331 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL:

Serious 62.8%Non-Serious 37.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female188 (60.6%)
Male122 (39.4%)

Reports by Age

Age 7114 reports
Age 7211 reports
Age 6910 reports
Age 638 reports
Age 708 reports
Age 597 reports
Age 667 reports
Age 687 reports
Age 767 reports
Age 526 reports
Age 576 reports
Age 626 reports
Age 796 reports
Age 565 reports
Age 585 reports
Age 675 reports
Age 244 reports
Age 354 reports
Age 424 reports
Age 544 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL?

This profile reflects 769 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL?

Frequently reported terms in FAERS include FATIGUE, PNEUMONIA, COVID-19, DIARRHOEA, FALL, DYSPNOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL?

Labeling and FAERS entries often list Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.