GEMS MENTHOL EUCALYPTUS- menthol lozenge

Gems by

Drug Labeling and Warnings

Gems by is a Otc medication manufactured, distributed, or labeled by Riclan S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GEMS  MENTHOL EUCALYPTUS
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71165-173
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.4 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	SQUARE	Size	18mm
Flavor	MENTHOL (MENTHOL EUCALYPTUS)	Imprint Code	G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71165-173-02	9 in 1 PACKAGE; Type 0: Not a Combination Product	09/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/13/2021

Labeler - Riclan S.A. (911989788)