SPL v1
SPL
SPL Set ID 2fb22181-aee3-d0bf-e063-6294a90a7865
Route
ORAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.8 mg)
Inactive Ingredients
Sambucus Nigra Flower Lemon Balm Oil Thyme Caramel Flavone Sucrose Glucose Tilia Cordata Flower Malva Neglecta Whole Wild Thyme Peppermint Sage Hyssopus Officinalis Whole Horehound

Identifiers & Packaging

Pill Appearance
Shape: oval Color: brown Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-05

Description

cough as may occur with a cold ocassional minor irritation and sore throat


Medication Information

Description

cough as may occur with a cold ocassional minor irritation and sore throat

Uses
  • cough as may occur with a cold
  • ocassional minor irritation and sore throat
Section 51945-4

Menthol

Active Ingredient

Menthol 4.8 mg

Warnings

Warnings

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

Directions
  • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
  • Children under 6 years: as a doctor
Questions?

Questions? or to report an adverse event call 1-888-423-0139

Other Information

Other information

  • 10 calories per drop
  • Store in a cool and dry place
Inactive Ingredients

Elderflower, Horehound, Hyssop, Lemon balm, Linden flowers, Mallow, Peppermint, Sage, Thyme, Wild thyme, Glucose syrup, Sucrose, Caramel color, Natural flavors

When Using This Product

When using this product

  • do not exceed recomended dosage
Indications & Usage Section

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat
Stop and Consult A Doctor If
  • cough persists for more than 7 days, tends to recur, or is accompanied 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.
If Pregnant Or Breast Feeding

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

Keep Out of the Reach of Children

Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (USES)
  • cough as may occur with a cold
  • ocassional minor irritation and sore throat
Section 51945-4 (51945-4)

Menthol

Active Ingredient

Menthol 4.8 mg

Warnings

Warnings

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

Directions
  • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
  • Children under 6 years: as a doctor
Questions?

Questions? or to report an adverse event call 1-888-423-0139

Other Information (Other information)

Other information

  • 10 calories per drop
  • Store in a cool and dry place
Inactive Ingredients

Elderflower, Horehound, Hyssop, Lemon balm, Linden flowers, Mallow, Peppermint, Sage, Thyme, Wild thyme, Glucose syrup, Sucrose, Caramel color, Natural flavors

When Using This Product (When using this product)

When using this product

  • do not exceed recomended dosage
Indications & Usage Section

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat
Stop and Consult A Doctor If (Stop and Consult a Doctor if)
  • cough persists for more than 7 days, tends to recur, or is accompanied 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.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

Keep Out of the Reach of Children (Keep out of the reach of children)

Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)