Gems 44-173

Drug Facts

Composition & Product

Active Ingredients

Menthol (8.4 mg)

Inactive Ingredients

Corn Syrup Eucalyptus Oil Fd&c Blue No. 1 Fd&c Red No. 40 Acacia Maltodextrin Lecithin, Soybean Sucrose Water

Identifiers & Packaging

Pill Appearance

Imprint: G Shape: square Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-13

Medication Information

Purpose

Cough suppressant/oral anesthetic

Description

Menthol 8.4 mg

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.

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

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

Active Ingredient (in Each Drop)

Menthol 8.4 mg

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)

Structured Label Content

Uses

temporarily relieves:

cough due to a cold
occasional minor irritation or sore throat

Purpose

Cough suppressant/oral anesthetic

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.

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 (Other information)

12 calories per drop
Contains: SOY

Inactive Ingredients (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 (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

Stop Use and Ask A Doctor If (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

Active Ingredient (in Each Drop) (Active ingredient (in each drop))

Menthol 8.4 mg

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "8.4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: cough due to a cold occasional minor irritation or sore throat", "Purpose": "Cough suppressant/oral anesthetic", "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.", "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", "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", "Active ingredient (in each drop)": "Menthol 8.4 mg", "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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information