Herbal cough drops

Manufacturer
Greenbrier International Inc. | Bestco Inc.
Effective date
2021-11-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:37

Label at a glance#

ProductHerbal cough drops
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each drop)

Menthol 4.8 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant / Oral anesthetic

INDICATIONS & USAGE SECTION

Uses temporarily relieves:

cough as may ocur with a cold or inhaled irritants

minor sore throat

WARNINGS SECTION

Warnings

Sore throat warning: 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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

OTC - ASK DOCTOR SECTION

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)

OTC - STOP USE SECTION

Stop use and ask doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 6 years and over - allow 2 drops to dissolve slowly in mouth, one at a time. May be repeated every 2 hours as necessary or as directed by a doctor.

children under 6 years - ask a doctor

OTHER SAFETY INFORMATION

Other information

17 calories per drop

INACTIVE INGREDIENT SECTION

Inactive ingredients: Caramel, corn starch, glucose syrup, herbal extract blend (Elderflower, Horehould, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), natural flavors, soybean oil, and sucrose.

OTC - QUESTIONS SECTION

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Assured Herbal 18ct Cough DropsAssured Herbal 18ct Cough Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637119menthol 4.8 MG Oral LozengePSN3
637119menthol 4.8 MG Oral LozengeSCD3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-1014-12023-01-30C16284748780-1f386c64a-447e-0266-e053-dadaa90a7c1aMenthol 4.8 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-1014-1Herbal cough drops18 in 1 BAGLOZENGE183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-1014HERBAL COUGH DROPS (MENTHOL) LOZENGE [GREENBRIER INTERNATIONAL INC.]3Legacy NDC, 1 package rows20211102_5fd98eab-e62c-8ea7-e053-2991aa0a12c2.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-101433992-1014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

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
cfbbcc94-2e8c-d226-e053-2a95a90aa8225fd98eab-e62c-8ea7-e053-2991aa0a12c22021-11-01WarningsExact identifier
spl id: cfbbcc94-2e8c-d226-e053-2a95a90aa822
spl set id: 5fd98eab-e62c-8ea7-e053-2991aa0a12c2

Reported adverse events (FAERS/openFDA)#

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