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  5. Label Information: Legend Cough Lozenge

FDA Label for Legend Cough Lozenge

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. KEEP OUT OF REACH OF CHILDREN
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Legend Cough Lozenge Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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