SPL v3
SPL
SPL Set ID 1ab295ff-94b1-c938-e063-6294a90a98fd
Route
ORAL
Published
Effective Date 2025-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.4 mg)
Inactive Ingredients
Lecithin, Soybean Sucrose Water Anhydrous Citric Acid Corn Syrup Sucralose Eucalyptus Oil Potassium Citrate

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: white Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01
Description

<(per drop) Menthol 5.4 mg>

Purpose

<Cough Suppressant, Oral Anesthetic>

Medication Information

Purpose

<Cough Suppressant, Oral Anesthetic>

Description

<(per drop) Menthol 5.4 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 by fever, headache, rash, swelling, or vomiting, consult a doctor promptly. These may be serious.>

Questions

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

Directions
  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor
Active Ingredient

<(per drop) Menthol 5.4 mg>

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

<citric acid, eucalyptus oil, flavors, glucose syrup, potassium citrate, soy lecithin, sucralose, sucrose, water>

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 by fever, headache, rash, swelling, or vomiting, consult a doctor promptly. These may be serious.>

Questions

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

Directions
  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor
Active Ingredient

<(per drop) Menthol 5.4 mg>

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

<citric acid, eucalyptus oil, flavors, glucose syrup, potassium citrate, soy lecithin, sucralose, sucrose, water>

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.175458 · Updated: 2026-03-14T23:09:57.827589