Herbal Throat Drops

Herbal Throat Drops
SPL v1
SPL
SPL Set ID 37dd58ad-95d1-568c-e063-6394a90a9433
Route
ORAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.1 mg)
Inactive Ingredients
Flavone Sage Wild Thyme Malva Sylvestris (mallow) Leaf Powder Ascorbic Acid Aspartame Citric Acid Monohydrate Lemon Balm Oil Horehound Hyssop Oil Linden Leaf Sambucus Nigra Flower Peppermint Beta Carotene Isomalt Thyme

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: yellow Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-18
Description

Active ingredient Menthol 1.1 mg

Medication Information

Warnings and Precautions

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious

Indications and Usage

Uses temporarily relieves:

ocassional minor irritation and pain associated with

  • sore mouth
  • sore throat

Dosage and Administration

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years: as a doctor
Description

Active ingredient Menthol 1.1 mg

Section 34088-5

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

Section 43683-2
  • Indications and Usage
  • Dosage and Administration
  • Contraindications
  • Warnings and Precautions
  • Inactive ingredients
Section 50565-1

Keep out of the reach of children.

Section 50566-9

Stop and consult a doctor if

  • sore throat is severe, or irritation, pain or redness last or worsens.
  • sore mouth does not improve in 7 days.
Section 50569-3

Stop and consult a doctor if

  • sore throat is severe, or irritation, pain or redness last or worsens.
  • sore mouth does not improve in 7 days.
Section 51727-6

ascorbic acid (Vitamin C), aspartame, citric acid, extract of lemon balm and others extract herbs (elder, horehound, hyssop, lemon balm,linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural color (beta-carotene), natural flavors.

Section 53413-1

Questions? or to report and adverse event call: 1-833-552-1767

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 associated with

  • sore mouth
  • sore throat
Section 55106-9

Active ingredient

  • Menthol 1.1 mg

Section 60561-8
  • Store in a cool and dry place
Front Package

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

ocassional minor irritation and pain associated with

  • sore mouth
  • sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years: as a doctor
Warnings and Precautions (34071-1)

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious

Section 34088-5 (34088-5)

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

Section 43683-2 (43683-2)
  • Indications and Usage
  • Dosage and Administration
  • Contraindications
  • Warnings and Precautions
  • Inactive ingredients
Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

Stop and consult a doctor if

  • sore throat is severe, or irritation, pain or redness last or worsens.
  • sore mouth does not improve in 7 days.
Section 50569-3 (50569-3)

Stop and consult a doctor if

  • sore throat is severe, or irritation, pain or redness last or worsens.
  • sore mouth does not improve in 7 days.
Section 51727-6 (51727-6)

ascorbic acid (Vitamin C), aspartame, citric acid, extract of lemon balm and others extract herbs (elder, horehound, hyssop, lemon balm,linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural color (beta-carotene), natural flavors.

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-833-552-1767

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 associated with

  • sore mouth
  • sore throat
Section 55106-9 (55106-9)

Active ingredient

  • Menthol 1.1 mg

Section 60561-8 (60561-8)
  • Store in a cool and dry place
Front Package

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:20.855813 · Updated: 2026-03-14T23:09:03.764166