ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by Kenvue Brands LLC

213 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE include CHOKING, DIARRHOEA, DRUG INEFFECTIVE, FOREIGN BODY IN THROAT, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

CHOKING15 reports
DIARRHOEA10 reports
DRUG INEFFECTIVE8 reports
FOREIGN BODY IN THROAT7 reports
DIZZINESS5 reports
INSOMNIA5 reports
DRUG ADMINISTRATION ERROR4 reports
NASAL CONGESTION4 reports
PRODUCT TASTE ABNORMAL4 reports
PRODUCT USE ISSUE4 reports
ABDOMINAL PAIN UPPER3 reports
DISORIENTATION3 reports
DRUG HYPERSENSITIVITY3 reports
DYSPNOEA3 reports
FOREIGN BODY IN RESPIRATORY TRACT3 reports
HALLUCINATION3 reports
HEADACHE3 reports
HYPERHIDROSIS3 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION3 reports
NAUSEA3 reports
PRODUCT ODOUR ABNORMAL3 reports
PRODUCT USE COMPLAINT3 reports
RASH3 reports
SOMNOLENCE3 reports
TREMOR3 reports
URTICARIA3 reports
ANXIETY2 reports
CONDITION AGGRAVATED2 reports
COUGH2 reports
DRUG ABUSE2 reports
DRUG SCREEN POSITIVE2 reports
DYSGEUSIA2 reports
ERYTHEMA2 reports
EXOPHTHALMOS2 reports
FACIAL PARALYSIS2 reports
FALL2 reports
FATIGUE2 reports
FEELING ABNORMAL2 reports
GAIT DISTURBANCE2 reports
HAEMATOCHEZIA2 reports
HYPERSENSITIVITY2 reports
INCOHERENT2 reports
INCORRECT DOSE ADMINISTERED2 reports
INTENTIONAL OVERDOSE2 reports
PRODUCT ADMINISTRATION ERROR2 reports
PRODUCT PACKAGING ISSUE2 reports
PRODUCT PHYSICAL ISSUE2 reports
RENAL PAIN2 reports
VISION BLURRED2 reports
VOMITING2 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS2 reports
ABDOMINAL DISCOMFORT1 reports
AGITATION1 reports
ANAL FISSURE1 reports
ANAL HAEMORRHAGE1 reports
ASCITES1 reports
ASPHYXIA1 reports
AURICULAR SWELLING1 reports
BACK PAIN1 reports
BLOOD CREATININE INCREASED1 reports
BLOOD PRESSURE INCREASED1 reports
BLOOD UREA INCREASED1 reports
CERVICAL VERTEBRAL FRACTURE1 reports
CHEST DISCOMFORT1 reports
CHEST PAIN1 reports
CHILLS1 reports
CLAVICLE FRACTURE1 reports
CONTRAINDICATED PRODUCT ADMINISTERED1 reports
COVID 191 reports
DEHYDRATION1 reports
DISCOMFORT1 reports
DISEASE RECURRENCE1 reports
DRUG INTERACTION1 reports
DYSPHAGIA1 reports
DYSURIA1 reports
ENERGY INCREASED1 reports
EUPHORIC MOOD1 reports
EXPIRED PRODUCT ADMINISTERED1 reports
FEAR1 reports
FLATULENCE1 reports
FOOD ALLERGY1 reports
FOOD POISONING1 reports
FOREIGN BODY1 reports
FUNCTIONAL GASTROINTESTINAL DISORDER1 reports
GASTROINTESTINAL HAEMORRHAGE1 reports
GASTROINTESTINAL MOTILITY DISORDER1 reports
GLUTATHIONE DECREASED1 reports
HAEMATEMESIS1 reports
HALLUCINATION, VISUAL1 reports
HEPATIC CIRRHOSIS1 reports
HYPERSOMNIA1 reports
INFLUENZA1 reports
INTENTIONAL PRODUCT MISUSE1 reports
INTENTIONAL PRODUCT USE ISSUE1 reports
LACRIMATION INCREASED1 reports
LIP SWELLING1 reports
LIVER INJURY1 reports
LOSS OF CONSCIOUSNESS1 reports
LYMPHADENOPATHY1 reports
MALAISE1 reports

Report Outcomes

Out of 85 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE:

Serious 67.1%Non-Serious 32.9%

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

Female56 (74.7%)
Male19 (25.3%)

Reports by Age

Age 154 reports
Age 242 reports
Age 392 reports
Age 402 reports
Age 482 reports
Age 572 reports
Age 592 reports
Age 632 reports
Age 642 reports
Age 672 reports
Age 752 reports
Age 782 reports
Age 862 reports
Age 872 reports
Age 01 reports
Age 121 reports
Age 131 reports
Age 251 reports
Age 261 reports
Age 291 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 HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 213 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include CHOKING, DIARRHOEA, DRUG INEFFECTIVE, FOREIGN BODY IN THROAT, DIZZINESS, INSOMNIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. 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.