Lemon Mint Drops Pastille
FDA Label NDC 82442-202
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation Inc. for the product Lemon Mint Drops (NDC 82442-202). 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:
ocasional minor irritation and pain associated with
- sore mouth
- sore throat
Indications & Usage
Uses temporarily relieves:
ocasional 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 symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious .
Otc - Ask Doctor
Stop and consult a doctor if
- sore mouth does not improve in 7 days.
- sore throat is severe, or irritation, pain or redness lasts or worsens.
Otc - Stop Use
Stop and consult a doctor if
sore mouth does not improve in 7 days.
sore throat is severe, or irritation, pain or redness lasts 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 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: 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
- 5 calories per dop
- Store in a cool and dry place
- Phenylketonurics, contains phenylalanine
- Excessive use may have a laxative effect.
- Product may be useful for diabetics
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: 1-800-910-68-74
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