EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT

Manufacturer
Ricola Ag
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:40:42

Key Label Information#

Active Ingredients And Purpose

Drug Facts

Purpose Cough suppressant

Active Ingredient (in each drop)

Menthol, 8.3 mg

Uses

Uses

temporarily relieves: cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants

Warnings

Warnings

Stop use and ask a doctor if

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

Directions And Dosage

Directions

adults and children 6 years and older: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor children under 6 years: ask a doctor

Other Label Information

Other Information

Store in a dry place

Inactive Ingredients

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

Label Images#

ExtraStrGlacierMint19ct
ExtraStrGlacierMint19ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1424614menthol 8.3 MG Oral LozengePSN7
1424614menthol 8.3 MG Oral LozengeSCD7

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-617-04EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT4 in 1 PACKAGELOZENGE47
54305-617-19EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT19 in 1 BAGLOZENGE197
54305-617-26EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT26 in 1 BAGLOZENGE267

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-617EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]7Current NDC, Legacy NDC, 3 package rows20241207_ea42e516-2ef8-41c9-ae4e-571f0147bc6b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
INVERT SUGARINACTIVE INGREDIENTED959S6ACY2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2B2
SUCROSEINACTIVE INGREDIENTC151H8M5542

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54305-61754305-617-19, 54305-617-26, 54305-617-04

Ingredients#

Complete SPL Sections#

Drug Facts

OTC - PURPOSE SECTION

Purpose Cough suppressant

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 8.3 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves: cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants

Warnings

WARNINGS SECTION

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

persistent chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and older: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor children under 6 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

Store in a dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

Source Document#

Source XML