ACETAMINOPHEN, PHENYLEPHRINE HCL

N/A

Manufactured by Better Living Brands, LLC

184 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, PHENYLEPHRINE HCL

ACETAMINOPHEN, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Better Living Brands, LLC. The most commonly reported adverse reactions for ACETAMINOPHEN, PHENYLEPHRINE HCL include PAIN, NAUSEA, PNEUMONIA, HEADACHE, SINUSITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, PHENYLEPHRINE HCL.

Top Adverse Reactions

PAIN8 reports
NAUSEA7 reports
PNEUMONIA6 reports
HEADACHE5 reports
SINUSITIS5 reports
ABDOMINAL PAIN UPPER4 reports
BACK PAIN4 reports
ACCIDENT3 reports
CONSTIPATION3 reports
COVID 193 reports
DIARRHOEA3 reports
DIZZINESS3 reports
DRUG INEFFECTIVE3 reports
DYSPNOEA3 reports
FATIGUE3 reports
INFLUENZA3 reports
PRODUCT DOSE OMISSION ISSUE3 reports
SINUS DISORDER3 reports
UPPER RESPIRATORY TRACT INFECTION3 reports
VOMITING3 reports
ABDOMINAL DISCOMFORT2 reports
ARTHRALGIA2 reports
ASTHENIA2 reports
ATRIAL FIBRILLATION2 reports
BLOOD IRON DECREASED2 reports
BLOOD POTASSIUM DECREASED2 reports
BRAIN NEOPLASM2 reports
BRAIN NEOPLASM MALIGNANT2 reports
CANDIDA INFECTION2 reports
DERMATITIS CONTACT2 reports
EPISTAXIS2 reports
INFUSION SITE PAIN2 reports
INJECTION SITE PRURITUS2 reports
INSURANCE ISSUE2 reports
JOINT INJURY2 reports
LOCAL SWELLING2 reports
MALAISE2 reports
MIDDLE EAR EFFUSION2 reports
NASOPHARYNGITIS2 reports
OCULAR DISCOMFORT2 reports
PRODUCT USE ISSUE2 reports
SEIZURE2 reports
STRESS2 reports
TOOTH ABSCESS2 reports
VIRAL INFECTION2 reports
VITAMIN B12 DECREASED2 reports
ABASIA1 reports
ABNORMAL FAECES1 reports
ABSCESS1 reports
AGEUSIA1 reports
ALANINE AMINOTRANSFERASE INCREASED1 reports
ANAL HAEMORRHAGE1 reports
ANOSMIA1 reports
ANXIETY1 reports
APATHY1 reports
ARRHYTHMIA1 reports
ARTHRITIS1 reports
ASPARTATE AMINOTRANSFERASE INCREASED1 reports
BACTERIAL INFECTION1 reports
BLADDER OPERATION1 reports
BOWEL MOVEMENT IRREGULARITY1 reports
BRAIN OEDEMA1 reports
BREAST CANCER1 reports
BRONCHITIS1 reports
BURNING SENSATION1 reports
CARDIAC FAILURE CONGESTIVE1 reports
CATARACT1 reports
CELLULITIS1 reports
CENTRAL NERVOUS SYSTEM LESION1 reports
CEREBROVASCULAR ACCIDENT1 reports
CHILLS1 reports
CHOKING1 reports
CHRONIC SINUSITIS1 reports
COLD SWEAT1 reports
COMA1 reports
CONTUSION1 reports
COUGH1 reports
CRYING1 reports
DEATH1 reports
DEMENTIA1 reports
DEPRESSED MOOD1 reports
DEREALISATION1 reports
DEVICE INFUSION ISSUE1 reports
DEVICE ISSUE1 reports
DISSOCIATION1 reports
DIVERTICULITIS1 reports
DRUG INTERACTION1 reports
DRY MOUTH1 reports
DRY THROAT1 reports
DYSGEUSIA1 reports
DYSMENORRHOEA1 reports
DYSURIA1 reports
EAR PAIN1 reports
EXPLORATORY OPERATION1 reports
EYE INFECTION1 reports
FAECES DISCOLOURED1 reports
FALL1 reports
FEAR1 reports
FLUSHING1 reports
GAIT INABILITY1 reports

Report Outcomes

Out of 43 classified reports for ACETAMINOPHEN, PHENYLEPHRINE HCL:

Serious 46.5%Non-Serious 53.5%

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

Female28 (65.1%)
Male15 (34.9%)

Reports by Age

Age 372 reports
Age 392 reports
Age 582 reports
Age 321 reports
Age 341 reports
Age 361 reports
Age 401 reports
Age 451 reports
Age 471 reports
Age 511 reports
Age 541 reports
Age 551 reports
Age 611 reports
Age 621 reports
Age 651 reports
Age 661 reports
Age 691 reports
Age 701 reports
Age 751 reports
Age 781 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, PHENYLEPHRINE HCL?

This profile reflects 184 FDA FAERS reports that mention ACETAMINOPHEN, 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, PHENYLEPHRINE HCL?

Frequently reported terms in FAERS include PAIN, NAUSEA, PNEUMONIA, HEADACHE, SINUSITIS, ABDOMINAL PAIN UPPER. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, PHENYLEPHRINE HCL?

Labeling and FAERS entries often list Better Living Brands, LLC in connection with ACETAMINOPHEN, 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.