FDA Label for Gems Menthol Eucalyptus
View Indications, Usage & Precautions
Gems Menthol Eucalyptus Product Label
The following document was submitted to the FDA by the labeler of this product Riclan S.a.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Drop)
Menthol 8.4 mg
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
* Please review the disclaimer below.