MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC

Manufacturer
Ricola USA Inc. | Ricola Ag
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:41:41

Label at a glance#

ProductMOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

temporarily relieves: cough due to a cold or inhaled irritants occasional minor irritation and pain due to sore throat or sore mouth

Dosage and administration

adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  Repeat every 2 hours as needed or as directed by a doctor children under 6 years: ask a doctor

Storage and handling

excessive use may have a laxative effect protect from heat and moisture product may be useful for diabetics on the advice of a doctor Exchange information:  2 Drops - FREE Exchange 7 Drops = 1 Fruit Dietary exchanges based on Exchange Lists for Diabetes ©2008 American Diabetes Association, American Dietetic Association.

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 4.8 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings

WARNINGS SECTION

Sore throat warnings:

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious,
  • do not use in children under 6 years of age unless directed by a doctor.

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.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  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

  • excessive use may have a laxative effect
  • protect from heat and moisture
  • product may be useful for diabetics on the advice of a doctor

Exchange information:  2 Drops - FREE Exchange

7 Drops = 1 Fruit

Dietary exchanges based on Exchange Lists for Diabetes

©2008 American Diabetes Association, American Dietetic Association.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, rebaudioside a, sorbitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of SFMountainHerbwStevia19ct.jpgImage of SFMountainHerbwStevia19ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637119menthol 4.8 MG Oral LozengePSN5
637119menthol 4.8 MG Oral LozengeSCD5

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-185-19MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 PACKAGELOZENGE195
63667-185-45MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC45 in 1 PACKAGELOZENGE455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-185MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]5Current NDC, Legacy NDC, 2 package rows20241211_b640a5d2-a7fe-486d-a65f-e7c993f950d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
CARAMELINACTIVE INGREDIENTT9D99G2B1R1
ISOMALTINACTIVE INGREDIENTS870P55O2W1
REBAUDIOSIDE AINACTIVE INGREDIENTB3FUD0528F1
SORBITOLINACTIVE INGREDIENT506T60A25R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63667-18563667-185-19, 63667-185-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
54 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
54 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
54 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
54 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.b640a5d2-a7fe-486d-a65f-e7c993f950d62024-12-10WarningsExact identifier
ndc (package): 63667-185-45
ndc (package): 63667-185-19
ndc (product): 63667-185
ndc11 (package): 63667018545
ndc11 (package): 63667018519
spl id: 701df832-b48f-45c2-a696-7da04a79c56d
spl set id: b640a5d2-a7fe-486d-a65f-e7c993f950d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.