FDA Label for Advanced Honey Lemon Cough Drops
View Indications, Usage & Precautions
Advanced Honey Lemon Cough Drops Product Label
The following document was submitted to the FDA by the labeler of this product Advanced First Aid, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient (in each lozenge) - Menthol 8.6mg
Otc - Purpose
Cough suppressant / Oral Anesthetic
Indications & Usage
Uses: temporarily relieves • cough as may occur with a 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. These smptoms may be serious.
Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
Stop use and consult a 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 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 baby, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
• Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.
• Children under 5 years: Consult a doctor.
Inactive Ingredient
corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose
Package Label.Principal Display Panel
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