Quality Choice Cough Drops Creamy Strawberry Lozenge
FDA Label NDC 83324-298
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 Creamy Strawberry (NDC 83324-298). 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)
Pectin 7 mg
Menthol 2.5 mg
Purposes
oral demulcent
cough suppressant, oral anesthetic
Uses
temporarily relieves the following symptoms associated with sore mouth and sore throat
• minor discomfort • irritated areas
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: • 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 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed. • children under 5 years: ask a doctor.
Other Information
• 15 calories per drop • contains: SOY.
Inactive Ingredients
beta carotene, citric acid, FD&C blue 2, FD&C red 40, flavors, menthol, glucose syrup, lactic acid, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, sucralose, water.
Questions?
call 800 935 2362 Monday-Friday 9AM-5PM EST
Packaging
Creamy Strawberry (8332429830)
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