Otc - Active Ingredient
Active Ingredient in each drop Purposes
Menthol 7.6 mg Cough Suppressant
Oral anesthetic
Front Label (Menthol150u Front)
Honey Lemon Cough Drops Pastille
FDA Label NDC 72628-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boston Nutraceutical Production Sl for the product Honey Lemon Cough Drops (NDC 72628-103). 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
Purposes
Cough suppressant/
Oral anesthetic
Indications & Usage
Uses Temporarily relieves:
- cough as may occur with cold or inhaled irritants
- ocassional minor irritations 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, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.
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 excessvie 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 irritation, pain or redness last 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 the reach of children.
Overdosage
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 over: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
- Children under 5 years: ask a doctor
Other Safety Information
Other information
- 6 calories per drop
- May be useful for diabetics on the advise of a doctor
- Excessive consumption may cause laxative effect
Inactive Ingredient
Citric acid, eucalyptus oil, isomalt, stevia, flavor lemon oil, flavor honey extract, colorant turmeric, water
Back Label (Honeylemon150uback)
Otc - Questions
Questions or comments call: 617-848-4560
Package Label.Principal Display Panel
Front Label (Menthol150u Front)
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