PHENOL: 89 Adverse Event Reports & Safety Profile

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Total FAERS Reports

11 (12.4%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Major Pharmaceuticals

Manufacturer

Route: ORAL · Manufacturer: Major Pharmaceuticals · HUMAN OTC DRUG · FDA Label: Available

First Report: 20010101 · Latest Report: 20250416

What Are the Most Common PHENOL Side Effects?

#1 Most Reported

Urticaria

16 reports (18.0%)

#2 Most Reported

Dyspnoea

16 reports (18.0%)

#3 Most Reported

Cough

13 reports (14.6%)

All PHENOL Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Dyspnoea	16	18.0%	0	8
Urticaria	16	18.0%	0	8
Cough	13	14.6%	0	7
Diarrhoea	12	13.5%	0	7
Drug ineffective	12	13.5%	1	5
Drug hypersensitivity	11	12.4%	0	6
Nausea	10	11.2%	0	6
Vomiting	10	11.2%	0	7
Angioedema	9	10.1%	0	9
Fatigue	9	10.1%	0	6
Wrong technique in product usage process	9	10.1%	1	6
Eye swelling	8	9.0%	0	7
Feeling abnormal	8	9.0%	0	6
Hypertension	8	9.0%	0	7
Off label use	8	9.0%	0	7
Pain in extremity	8	9.0%	0	8
Peripheral swelling	8	9.0%	0	7
Pruritus	8	9.0%	0	7
Toxicity to various agents	8	9.0%	6	3
Arthralgia	7	7.9%	0	6

Who Reports PHENOL Side Effects? Age & Gender Data

Gender: 47.4% female, 52.6% male. Average age: 39.3 years. Most reports from: US. View detailed demographics →

Is PHENOL Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2001	1	0	0
2010	1	1	0
2012	1	0	1
2013	1	0	0
2014	2	0	1
2015	5	0	2
2016	5	1	2
2017	1	0	0
2018	6	0	1
2019	3	0	2
2020	3	2	1
2022	2	0	1
2024	3	0	0
2025	5	0	1

View full timeline →

What Is PHENOL Used For?

Indication	Reports
Product used for unknown indication	18
Oropharyngeal pain	16
Rhinitis allergic	8
Cough	5
Seasonal allergy	5

Official FDA Label for PHENOL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Dosage & Administration

Directions Adults and children 3 years of age and older: Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out. Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Directions

Adults and children 3 years of age and older: Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out . Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Directions

Adults and children 3 years of age and older: Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out. Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Warnings

Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 3 years of age unless directed by a doctor. When using this product do not exceed recommended dosage. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings Sore Throat

Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 3 years of age unless directed by a doctor. When using this product do not exceed recommended dosage. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens fever, headache, swelling, rash, nausea or vomiting develops If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings Sore Throat

Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 3 years of age unless directed by a doctor. When using this product do not exceed recommended dosage. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient

Carbolicum acidum 200CK HPUS Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

Inactive Ingredients

Inactive ingredients Citric acid, FD&C Red #40, FD&C Yellow #6, flavor, glycerin, purified water, sodium saccharin, sodium citrate

Inactive ingredients FD&C red no. 40, flavors, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin, sucralose

Inactive ingredients D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, sodium saccharin, sucralose