SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS

Manufacturer
Ricola Ag
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:40:39

Key Label Information#

Active Ingredients And Purpose

Drug Facts

Purpose Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

Menthol, 4.8 mg

Uses

Uses

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

Warnings

Warnings

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.

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

Directions And Dosage

Directions

adults and children 6 years and older: dissolve 2 drops (one at a time) 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

Phenylketonurics: contains phenylalanine 1 mg per drop excessive use may have a laxative effect store in a dry place 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 Diabetics © 2008 American Diabetes Association, American Dietetic Association

Inactive Ingredients

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

Label Images#

SF Original Swiss Herb 19 ct
SF Original Swiss Herb 19 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637119menthol 4.8 MG Oral LozengePSN8
637119menthol 4.8 MG Oral LozengeSCD8

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-802-19SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS19 in 1 BAGLOZENGE198
54305-802-24SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS24 in 1 BAGLOZENGE248
54305-802-45SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS45 in 1 BAGLOZENGE458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-802SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]8Current NDC, Legacy NDC, 3 package rows20241207_b790a91c-33be-4bc3-bdeb-eae6f366f085.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR12
CARAMELINACTIVE INGREDIENTT9D99G2B1R2
ISOMALTINACTIVE INGREDIENTS870P55O2W2
SORBITOLINACTIVE INGREDIENT506T60A25R2

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54305-80254305-802-19, 54305-802-24, 54305-802-45

Ingredients#

Complete SPL Sections#

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

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 2 drops (one at a time) 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

Phenylketonurics: contains phenylalanine 1 mg per drop excessive use may have a laxative effect store in a dry place 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 Diabetics © 2008 American Diabetes Association, American Dietetic Association

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Source Document#

Source XML