Otc - Active Ingredient
Active Ingredient in each drop Purposes
Menthol 5.4 mg
Cough Suppressant
Oral Anesthetic
Front Panel (20220812 09378 Bobina Menthol 30u Pectol Usa Frontal)
Menthol Cough Drops Pastille
FDA Label NDC 72628-118
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 Menthol Cough Drops (NDC 72628-118). 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 ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Indications & Usage
Purposes
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Warnings
Warnings
Sore throat warning: severe or persistant sore throat accompanied by high fever headache, nausea and vomiting maybe serious Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years old.
Otc - Ask Doctor
Ask a doctor before use if you have:
- a severe throat accompanied by difficulty in breathing or that lasts more than 2 days
- a sore throat accompanied by fever, headache, rash, swelling, nausea and vomiting
Otc - Stop Use
Stop use and consult doctor if
- sore mouth symptons does not improve in 7 days or if,
- irritation, pain or redness persists or worsens
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep 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 12 years and over: dissolve 1 drop slowly in mouth. Repeat every two hours as needed or as directed by a doctor.
- Children under 12 years do not use
Other Safety Information
Other information
- Store in a cool and dry place
- 11 calories per drop
Inactive Ingredient
glucose, syrup, sucrose
Otc - Questions
Questions or to report an adverse event call:
1 833 5521737
Package Label.Principal Display Panel
Back Panel (20220812 09378 Bobina Menthol 30u Pectol Usa Trasera)
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