Quality Choice Cough Drops Vanilla Honey Lozenge
FDA Label NDC 83324-308
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Quality Choice Cough Drops Vanilla Honey (NDC 83324-308). 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 (per drop), 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 (Per Drop)
Menthol 2.5 mg
Purposes
cough suppressant, oral anesthetic
Uses
temporary relieves:
• cough due to cold • occasional minor irritation or sore throat
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.
Ask a doctor before use if you have: • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus).
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. These could be signs of a serious condition. • sore mouth does not improve in 7 days • irritation, pain, or redness persists or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
• adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed • children under 5 years: ask a doctor.
Other Information
• 10 calories per drop • contains: SOY.
Inactive Ingredients
beta carotene, flavors, glucose syrup, honey, soy lecithin, sucrose, water.
Questions?
Call 800 935 2362 Monday-Friday 9AM-5PM EST
Packaging
Vanilla Honey (8332430830)
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