Legend

Legend
SPL v1
SPL
SPL Set ID b56b8338-184b-4a65-85ab-7491b4b0c4fe
Route
ORAL
Published
Effective Date 2020-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 mg)
Inactive Ingredients
Honey Ginger Licorice Eucalyptol Plectranthus Amboinicus Whole Cinnamon Oil Mannitol Sorbitol Povidone K30 Xylitol Silicon Dioxide Magnesium Stearate Aspartame Sucralose Sodium Benzoate Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-04-15

Description

Menthol

Purpose

Cough Suppressant/ Oral Anesthetic


Medication Information

Purpose

Cough Suppressant/ Oral Anesthetic

Description

Menthol

Uses

Temporarily suppresses/relieves:

  • Coughs due to minor throat and bronchial irritation from a cold or inhaled irritant
  • Occasional minor sore throat pain
Warnings



Ask a doctor before use if you have

  • Chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
  • Cough that occurs with too much phlegm (mucus)

When using this product

Do not use more than directed, taking more may have a laxative effect

Stop use and ask a doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition
  • Sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
  • Sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens
Directions
  • Dissolve a lozenge slowly in mouth.
  • May be repeated every hour for coughs as needed or as directed by a doctor.
  • May be repeated every 2 hours for sore throat.
  • Do not take more than 10 lozenges per day.
Product Label

Active Ingredient

Menthol

Inactive Ingredients

Honey powder, Ginger extract, Licorice extract, Eucalyptol oil, Mexican Mint oil, Cinnamon oil, Mannitol, Sorbitol, Povidone K30, Xylitol, Silicone Dioxide, Magnesium stearate, Aspartame, Sucralose, Sodium benzoate, FD&C Yellow No. 5, FD&C Blue No. 1

Keep Out of Reach of Children
  • Adults and children 6 years and older 10 mg
  • Children under 6 years ask a doctor

Structured Label Content

Uses

Temporarily suppresses/relieves:

  • Coughs due to minor throat and bronchial irritation from a cold or inhaled irritant
  • Occasional minor sore throat pain
Purpose

Cough Suppressant/ Oral Anesthetic

Warnings



Ask a doctor before use if you have

  • Chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
  • Cough that occurs with too much phlegm (mucus)

When using this product

Do not use more than directed, taking more may have a laxative effect

Stop use and ask a doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition
  • Sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
  • Sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens
Directions
  • Dissolve a lozenge slowly in mouth.
  • May be repeated every hour for coughs as needed or as directed by a doctor.
  • May be repeated every 2 hours for sore throat.
  • Do not take more than 10 lozenges per day.
Product Label

Active Ingredient

Menthol

Inactive Ingredients

Honey powder, Ginger extract, Licorice extract, Eucalyptol oil, Mexican Mint oil, Cinnamon oil, Mannitol, Sorbitol, Povidone K30, Xylitol, Silicone Dioxide, Magnesium stearate, Aspartame, Sucralose, Sodium benzoate, FD&C Yellow No. 5, FD&C Blue No. 1

Keep Out of Reach of Children (Keep out of reach of children)
  • Adults and children 6 years and older 10 mg
  • Children under 6 years ask a doctor

Advanced Ingredient Data


Raw Label Data

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