severe throat drops

Drug Facts

Composition & Product

Active Ingredients

menthol (20 mg)

Inactive Ingredients

eucalyptol fd&c blue no. 1 acacia sucrose corn syrup

Identifiers & Packaging

Pill Appearance

Imprint: None Shape: oval Color: white Size: 25 mm

Marketing Status

otc monograph drug active Since 2024-05-15

Medication Information

Warnings and Precautions

Warnings

Sore throat warning: severe or persistence 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 administer to children under 12 years of age.

Active Ingredient

Active ingredient 20 mg

Oral anesthetic

Indications and Usage

Uses temporarily relieves ocassional minor irritation and pain due to:

Sore throat
Sore mouth

Dosage and Administration

Directions

Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
Children under 12 years and under do not use

Description

Active ingredient 20 mg Oral anesthetic

Section 34088-5

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50566-9

Stop use and consult a doctor if

sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.

Section 50569-3

Ask a doctor before use if you have

a severe throat accompanied by difficulty in breathing or that last more than 2 days
a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

Section 51727-6

eucalytus oil, FD&C blue No.1, glucose syrup, gum arabic, sucrose

Section 51945-4

Section 53413-1

Questions? or to report and adverse event call: 1-800-910-68-74

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses temporarily relieves ocassional minor irritation and pain due toL

Sore throat
Sore mouth

Section 60561-8

Store in a cool and dry place

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Sore throat warning: severe or persistence 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 administer to children under 12 years of age.

Active Ingredient (55106-9)

Active ingredient 20 mg

Oral anesthetic

Indications and Usage (34067-9)

Uses temporarily relieves ocassional minor irritation and pain due to:

Sore throat
Sore mouth

Dosage and Administration (34068-7)

Directions

Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
Children under 12 years and under do not use

Section 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50566-9 (50566-9)

Stop use and consult a doctor if

sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

a severe throat accompanied by difficulty in breathing or that last more than 2 days
a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

Section 51727-6 (51727-6)

eucalytus oil, FD&C blue No.1, glucose syrup, gum arabic, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-800-910-68-74

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses temporarily relieves ocassional minor irritation and pain due toL

Sore throat
Sore mouth

Section 60561-8 (60561-8)

Store in a cool and dry place

Advanced Ingredient Data

[{"name": "EUCALYPTOL", "unii": "RV6J6604TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves ocassional minor irritation and pain due to: Sore throat Sore mouth", "34068-7": "Directions Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor. Children under 12 years and under do not use", "34071-1": "Warnings Sore throat warning: severe or persistence 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 administer to children under 12 years of age.", "34088-5": "In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50565-1": "Keep this and all drugs out of the reach of children.", "50566-9": "Stop use and consult a doctor if sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.", "50569-3": "Ask a doctor before use if you have a severe throat accompanied by difficulty in breathing or that last more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting", "51727-6": "eucalytus oil, FD&C blue No.1, glucose syrup, gum arabic, sucrose", "53413-1": "Questions? or to report and adverse event call: 1-800-910-68-74", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses temporarily relieves ocassional minor irritation and pain due toL Sore throat Sore mouth", "55106-9": "Active ingredient 20 mg Oral anesthetic", "60561-8": "Store in a cool and dry place"}