Otc - Active Ingredient
Active Ingredient (in each lozenge) - Menthol 8.6mg
Advanced Honey Lemon Cough Drops
FDA Label NDC 67060-121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Advanced Honey Lemon Cough Drops (NDC 67060-121). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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 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
Honey Lemon Cough Drops 100ct Carton (Honeylemon Coughdrops1214 8 6 19)
Honey Lemon Cough Drops 100ct Carton (Honeylemon Coughdrops1214 8 6 19)
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