Sugar Free Menthol Cough Drops

Sugar Free Menthol Cough Drops
SPL v1
SPL
SPL Set ID 3eab4cf9-6fdc-a6fb-e063-6394a90a8633
Route
ORAL
Published
Effective Date 2025-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (7.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Corn Syrup Honey Flavone Turmeric Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: yellow Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-13

Description

Active Ingredient: Menthol 7.5 mg.............cough suppresant/ oral anesthetic


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.

Indications and Usage

Uses temporarily relieves:

cough as may occur with a cold



ocassional minor irritation and sore throat

Dosage and Administration

Directions

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

Active Ingredient: Menthol 7.5 mg.............cough suppresant/ oral anesthetic

Section 34088-5

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

Section 43683-2
  • Directions
  • Stop and consult a doctor
  • Warning
Section 50565-1

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

Section 50566-9

Stop and consult a doctor before use if

  • cough persist 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 symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 50569-3

Stop and consult a doctor before use if

  • cough persist 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 symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 51727-6

citric acid, glucose syrup, honey, natural flavors, sucrose, turmeric (for coloring)

Section 51945-4

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:

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

Active Ingredient:

  • Menthol 7.5 mg.............cough suppresant/ oral anesthetic
Section 60561-8
  • 10 calories per drop
  • Store in a cool and dry place

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

cough as may occur with a cold



ocassional minor irritation and sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in the 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 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.

Section 34088-5 (34088-5)

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

Section 43683-2 (43683-2)
  • Directions
  • Stop and consult a doctor
  • Warning
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop and consult a doctor before use if

  • cough persist 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 symptoms 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 before use if

  • cough persist 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 symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Section 51727-6 (51727-6)

citric acid, glucose syrup, honey, natural flavors, sucrose, turmeric (for coloring)

Section 51945-4 (51945-4)

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:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat
Section 55106-9 (55106-9)

Active Ingredient:

  • Menthol 7.5 mg.............cough suppresant/ oral anesthetic
Section 60561-8 (60561-8)
  • 10 calories per drop
  • Store in a cool and dry place

Advanced Ingredient Data


Raw Label Data

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