Cough Drops

Manufacturer
Topco Associates LLC | Boston Nutraceutical Science SL | Boston Nutraceutical Production SL
Effective date
2022-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:52:32

Label at a glance#

ProductCough Drops
Active ingredientMENTHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient 7.5 mg

Cough Suppressant

Oral anesthetic

Front PanelFront Panel

OTC - PURPOSE SECTION

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat

INDICATIONS & USAGE SECTION

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat

WARNINGS SECTION

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a severe throat accompanied by difficulty in breathing or that last more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.

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 this and all drugs out of the reach of children.

OVERDOSAGE SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 12 years and under do not use

OTHER SAFETY INFORMATION

  • Store in a cool and dry place
  • 10 calories per drop

INACTIVE INGREDIENT SECTION

citric acid, honey, flavors, glucose syrup, sucrose, turmeric

OTC - QUESTIONS SECTION

Questions? or to report and adverse event call: 1-800-423-0139

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BackBack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76162-017-012024-01-30C16284748780-11030e365-3a93-111a-e063-dadaa90a10e2Cough Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-017-01Cough Drops80 in 1 BAGPASTILLE801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-017COUGH DROPS (MENTHOL) PASTILLE [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20221217_eff64fd9-8318-3388-e053-2995a90aef37.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-01776162-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
eff64fd9-8319-3388-e053-2995a90aef37eff64fd9-8318-3388-e053-2995a90aef372022-12-16WarningsExact identifier
spl id: eff64fd9-8319-3388-e053-2995a90aef37
spl set id: eff64fd9-8318-3388-e053-2995a90aef37

Reported adverse events (FAERS/openFDA)#

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