SPL v4
SPL
SPL Set ID 1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2
Route
ORAL
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Sucrose Beta Carotene Eucalyptus Oil Fd&c Blue No. 1 Corn Syrup Malic Acid Soybean Lecithin Potassium Citrate Water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-24 Until 2024-11-20

Description

Menthol 2.5 mg

Purpose

Cough suppressant, Oral anesthetic


Medication Information

Purpose

Cough suppressant, Oral anesthetic

Description

Menthol 2.5 mg

Uses

Temporarily relieves:

  • cough due to a cold
  • occasional minor irritation or sore throat.
Section 51945-4

Purposes

Cough suppressant, Oral anesthetic

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. These may be serious.

Directions
  • adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed
  • children under 5 years: ask a doctor
Questions?

Call 1-800-524-2854, Monday to Friday, 9 AM - 6 PM Eastern Time or visit our website at www.gethalls.com

Other Information
  • 10 Calories per drop
  • Contains: SOY.
Inactive Ingredients

beta carotene, citric acid, eucalyptus oil, FD&C blue 1, flavors, glucose syrup, malic acid, potassium

citrate, soy lecithin, sucrose, water

Active Ingredient (per Drop)

Menthol 2.5 mg

Stop Use and Ask A Doctor If:
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days – irritation, pain, or redness persists or worsens
Ask A Doctor Before Use If You Have:
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema - cough accompanied by excessive phlegm (mucus)

Structured Label Content

Uses

Temporarily relieves:

  • cough due to a cold
  • occasional minor irritation or sore throat.
Section 51945-4 (51945-4)

Purposes

Cough suppressant, Oral anesthetic

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. These may be serious.

Directions
  • adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed
  • children under 5 years: ask a doctor
Questions?

Call 1-800-524-2854, Monday to Friday, 9 AM - 6 PM Eastern Time or visit our website at www.gethalls.com

Other Information
  • 10 Calories per drop
  • Contains: SOY.
Inactive Ingredients (Inactive ingredients)

beta carotene, citric acid, eucalyptus oil, FD&C blue 1, flavors, glucose syrup, malic acid, potassium

citrate, soy lecithin, sucrose, water

Active Ingredient (per Drop) (Active ingredient (per drop))

Menthol 2.5 mg

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days – irritation, pain, or redness persists or worsens
Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema - cough accompanied by excessive phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)