severe throat drops oral anesthetic

severe throat drops oral anesthetic
SPL v3
SPL
SPL Set ID 949543d5-5043-ac06-e053-2995a90ab398
Route
oral
Published
Effective Date 2019-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.69 mg)
Inactive Ingredients
eucalyptus oil fd&c blue no. 1 water acacia sucrose corn syrup

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: rectangle Color: white Size: 17 mm
Marketing Status
otc monograph drug active Since 2019-10-12
Description

Active Ingredient in each drop Purposes Menthol 20mg Cough Suppressant Oral anesthetic

Medication Information

Warnings and Precautions

Warnings

Sore throat warning: severe or persistence sore throat accompanied or followed 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 in each drop Purposes

Menthol 20mg Cough Suppressant

Oral anesthetic

Indications and Usage

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 in each drop Purposes Menthol 20mg Cough Suppressant 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

eucalyptus 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: 1-617-848-4560

Monday to Friday 9AM to 4 PM east

Section 53414-9

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

Section 55105-1

Temporarily relieves ocassional minor irritation and pain due to:

  • 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 or followed 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 in each drop Purposes

Menthol 20mg Cough Suppressant

Oral anesthetic

Indications and Usage (34067-9)

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)

eucalyptus 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: 1-617-848-4560

Monday to Friday 9AM to 4 PM east

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Temporarily relieves ocassional minor irritation and pain due to:

  • sore throat
  • sore mouth
Section 60561-8 (60561-8)
  • Store in a cool and dry place

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:41.563079 · Updated: 2026-03-14T23:03:53.608631