GEMS MENTHOL EUCALYPTUS- menthol lozenge 
Riclan S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gems 44-173

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

Keep out of reach of children.

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


GEMS  MENTHOL EUCALYPTUS
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71165-173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.4 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ACACIA (UNII: 5C5403N26O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeSQUARESize18mm
FlavorMENTHOL (MENTHOL EUCALYPTUS) Imprint Code G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71165-173-029 in 1 PACKAGE; Type 0: Not a Combination Product09/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/13/2021
Labeler - Riclan S.A. (911989788)

Revised: 9/2022
Document Id: d22dc185-79f0-4a71-be1a-f1b32df6db6b
Set id: 853254be-2d3b-46a8-97b9-8532f771a828
Version: 2
Effective Time: 20220917
 
Riclan S.A.