Otc - Active Ingredient
(In each lozenge)
Organic Menthol 5mg
Meyer Lemon And Honey-cough Relief Lozenges (oral Anesthetic)
FDA Label NDC 70084-614
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quantum, Inc. for the product Meyer Lemon And Honey-cough Relief Lozenges (oral Anesthetic) (NDC 70084-614). 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 otc - active ingredient, otc - purpose, warnings, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antitussive (Cough Suppressant) / Oral Anesthetic
Warnings
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by a physician.
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you have:
- persistent or chronic cough as occurs with smoking, asthma, or emphysema.
- cough that occurs with excessive phlegm (mucus).
Otc - Stop Use
- 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5years of age: ask a doctor.
Other Safety Information
Store in a cool, dry place.
Inactive Ingredient
Organic Brown Rice Syrup, Organic Cane Syrup, Organic Honey, Natural Meyer Lemon Flavor and Other Natural Flavors, Organic Slippery Elm Bark Powder, and Organic Tumeric.
Indications & Usage
- cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritation,
- occasional minor irritation, pain, sore mouth, and sore throat.
* Please review the disclaimer below.
