Otc - Active Ingredient
Active ingredient
- Menthol 1.1 mg
Herbal Throat Drops Pastille
FDA Label NDC 79481-0024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Herbal Throat Drops (NDC 79481-0024). 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
Uses temporarily relieves:
ocassional minor irritation and pain associated with
- sore mouth
- sore throat
Indications & Usage
Uses temporarily relieves:
ocassional minor irritation and pain associated with
- sore mouth
- 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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious
Otc - Ask Doctor
Stop and consult a doctor if
- sore throat is severe, or irritation, pain or redness last or worsens.
- sore mouth does not improve in 7 days.
Otc - Stop Use
Stop and consult a doctor if
- 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 out of the reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
- Children under 6 years: as a doctor
Other Safety Information
- Store in a cool and dry place
Inactive Ingredient
ascorbic acid (Vitamin C), aspartame, citric acid, extract of lemon balm and others extract herbs (elder, horehound, hyssop, lemon balm,linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural color (beta-carotene), natural flavors.
Otc - Questions
Questions? or to report and adverse event call: 1-833-552-1767
Recent Major Changes
- Indications and Usage
- Dosage and Administration
- Contraindications
- Warnings and Precautions
- Inactive ingredients
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