Otc - Active Ingredient
Active Ingredient (in each drop)
Menthol 2.7mg
Strawberry Cough Drops Lozenge
FDA Label NDC 52642-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bestco Inc. for the product Strawberry Cough Drops (NDC 52642-020). 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, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Cough suppressant
Oral anesthetic
Indications & Usage
Uses
Temporarily relieves:
- cough as may occur with cold
- occasional minor irritation and sore throat
Warnings
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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.
Otc - Ask Doctor
Ask a doctor before use if you have:
- persisten or chronic cough such as occurs with smoking, asthma, or emphysema.
- cough accompanied by excessive phlegm (mucus)
Otc - Stop Use
Stop Use and Consult Doctor If
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.
- these could be signs of a serious condition.
- sore throat is severe, or if irritation, pain or redness lasts or worsens.
- sore mouth does 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 this and all drugs out of reach of chidren.
Dosage & Administration
Directions
Adults and children 5 years and over, allow 2 drops to dissolve in mouth slowly, one at a time. May be repeated every 2 hours a necessary or as directed by a doctor.
Children under 5 years, ask a doctor
Inactive Ingredient
Inactive Ingredients:
citric acid, eucalyptus oil, FD&C Red #40, glucose syrup, N & A flavoring, sucrose, water. Soybean oil and cornstarch used as processing aids.
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