Otc - Active Ingredient
Active Ingredient in each drop Purposes
Menthol 4.8 mg
Cough Suppressant
Oral Anesthetic
Natural Herbal Cough Drops Pastille
FDA Label NDC 72628-107
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, S.l for the product Natural Herbal Cough Drops (NDC 72628-107). 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
Temporarily relieves :
- cough as may occur with a cold
- occasional minor irritation and sore throat
Indications & Usage
Purposes
Temporarily relieves :
- cough as may occur with a cold
- occasional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons 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 ephysema.
- Cough accompanied by excessive pleghm (mucus)
Otc - Stop Use
Stop use and consult doctor if
- cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions
- 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, 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 6 years and over: allow 2 drops to dissolve slowly in mouth one at a time. Maybe repeated every two hours as needed or as directed by a doctor.
- Children under 6 years ask a doctor
Other Safety Information
Other information
- Store in a cool and dry place
- 11 calories per drop
Inactive Ingredient
corn syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours
Otc - Questions
Questions or to report an adverse event call:
1 617-848-4560
Monday to Friday: 9:00 am to 4:00 pm ET
Package Label.Principal Display Panel
Label (Frontal)
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