Legend Cough Lozenge
FDA Label NDC 13411-842

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals for the product Legend Cough Lozenge (NDC 13411-842). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, keep out of reach of children, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol

Purpose

Cough Suppressant/ Oral Anesthetic

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.

Keep Out Of Reach Of Children

  • Adults and children 6 years and older 10 mg
  • Children under 6 years ask a doctor

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

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