Active Ingredient (In Each Drop)
Menthol 8.4 mg
Gems Lozenge
FDA Label NDC 71165-173
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Riclan S.a. for the product Gems (NDC 71165-173). 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 active ingredient (in each drop), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant/oral anesthetic
Uses
temporarily relieves:
- cough due to a cold
- occasional minor irritation or sore throat
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor.
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
Stop Use And Ask A Doctor If
- sore mouth does not improve in 7 days
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- irritation, pain, or redness persists or worsens
Directions
- do not take more than directed
- adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
- children under 5 years: ask a doctor
Other Information
- 12 calories per drop
- Contains: SOY
Inactive Ingredients
corn syrup, eucalyptus oil, FD&C blue #1, FD&C red #40, gum arabic, maltodextrin, natural flavor, soy lecithin, sucrose, water
Principal Display Panel
Menthol • Cough Suppressant • Oral Anesthetic
Gems™
MENTHOL
EUCALYPTUS
FLAVOR
9 DROPS
Distributed by Gems™ Drops, LLC,
Hauppauge, NY 11788 1-844-632-7898
Gems 44-173 (Gems 44 173 1)
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