Active Ingredient(S)
Menthol 4.8 mg
Hyvee Cough Drops Original Herb Lozenge
FDA Label NDC 42507-906
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hy-vee, Inc for the product Hyvee Cough Drops Original Herb (NDC 42507-906). 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 active ingredient(s), purpose, use, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purposes cough suppressant, oral anesthetic
Use
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.
Otc - Ask Doctor
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).
Otc - Stop Use
Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does 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 reach of children
Directions
■ adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or directed by doctor.
■ children under 2 years: 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
caramel, corn syrup, flavors, herbal extract blend (elderflower extract, horehound extract, hyssop extract, lemon balm extract, linden flower extract, malva sylvestris (mallow) leaf extract, peppermint extract, sage extract, thyme extract, wild thyme extract), SOY LECHITIN, sucrose, water
Otc - Questions
Call +1-866-306-9136
You may also report concerns to this phone number
Monday to Friday, 9 AM - 5 PM Eastern Time
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