Leader Cough Drops Vanilla Honey Lozenge
FDA Label NDC 70000-0692
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Cough Drops Vanilla Honey (NDC 70000-0692). 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 drug facts, active ingredient (in each lozenge), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Lozenge)
Menthol 2.5 mg
Purposes
Cough suppressant/oral anesthetic
Uses
temporarily relieves:
• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat
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.
Ask a doctor before use if you have
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
When using this product do not exceed recommended dosage
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. A persistent cough may be a sign of a serious condition
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Directions
• adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
• children under 2 years of age: ask a doctor
Other Information
• store at room temperature.
• keep away from excessive heat or sunlight
• do not use if primary bag seal has been torn or broken.
• contains: SOY
Inactive Ingredients
beta carotene, corn syrup, honey, soy lecithin, sucrose, vanilla flavor, water.
Questions Or Comments?
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Packaging
Vanilla Honey (70000069 21)
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