Natural Lemon Mint Herb Throat Drops Lozenge
FDA Label NDC 63667-957

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ricola Usa Inc. for the product Natural Lemon Mint Herb Throat Drops (NDC 63667-957). 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 drug facts, active ingredient (in each drop), uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Purpose

Oral anesthetic

Active Ingredient (In Each Drop)

Menthol, 1.5 mg

Uses

temporarily relieves occasional minor irritation and pain associated with:

  • sore mouth
  • sore throat

Warnings

Do not use

  • in children under 6 years of age unless directed by a doctor.

Stop Use And Ask A Doctor If

  • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.
  • sore mouth symptoms do not improve in 7 days.

Keep Out Of Reach Of Children.


Directions

  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

Store in a dry place

Inactive Ingredients

Citric acid, extracts of lemon balm and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural color (beta-carotene), natural flavors, starch syrup, sugar

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