Herbal Throat Drops

Herbal Throat Drops
SPL v1
SPL
SPL Set ID 380364be-4e52-fa52-e063-6394a90a713c
Route
ORAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.8 mg)
Inactive Ingredients
Corn Syrup Flavone Sage Wild Thyme Malva Sylvestris (mallow) Leaf Powder Lemon Balm Oil Horehound Hyssop Oil Linden Leaf Peppermint Caramel Sucrose Thyme

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: brown Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20

Description

Active ingredient Menthol 1.1 mg


Medication Information

Warnings and Precautions

Warnings

Sore throat warning: Severe, persistent sore throat accompanied by fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

Indications and Usage

Uses temporarily relieves:

  • coug as may occur with a cold
  • occasional minor irritation and 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

  • Cough persists for more than 7 days, tends to recur, or is accompanid by fever, rash or persistent headache. These could be signs of a serious condition.
  • Sore mouth symptons do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 50569-3

Stop and consult a doctor if

  • Cough persists for more than 7 days, tends to recur, or is accompanid by fever, rash or persistent headache. These could be signs of a serious condition.
  • Sore mouth symptons do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 51727-6

caramel color, blend of herbs extract (elderflower, horehound, hyssop, lemon balm, liden flowers, mallow, peppermint, sage, thyme, wild thyme), glucose syrup, natural flavors, sucrose.

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:

  • coug as may occur with a cold
  • occasional minor irritation and sore throat
Section 55106-9

Active ingredient

  • Menthol 1.1 mg

Section 60561-8
  • Store in a cool and dry place
  • 10 calories per drop
Front Package

Front Panel


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

  • coug as may occur with a cold
  • occasional minor irritation and 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: Severe, persistent sore throat accompanied by fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

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

  • Cough persists for more than 7 days, tends to recur, or is accompanid by fever, rash or persistent headache. These could be signs of a serious condition.
  • Sore mouth symptons do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 50569-3 (50569-3)

Stop and consult a doctor if

  • Cough persists for more than 7 days, tends to recur, or is accompanid by fever, rash or persistent headache. These could be signs of a serious condition.
  • Sore mouth symptons do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 51727-6 (51727-6)

caramel color, blend of herbs extract (elderflower, horehound, hyssop, lemon balm, liden flowers, mallow, peppermint, sage, thyme, wild thyme), glucose syrup, natural flavors, sucrose.

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:

  • coug as may occur with a cold
  • occasional minor irritation and 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
  • 10 calories per drop
Front Package

Front Panel


Advanced Ingredient Data


Raw Label Data

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