FDA.reportPublic FDA data

Menthol Cough Drops

Manufacturer
LA TIA TRINI SA DE CV
Effective date
2021-07-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:43

Label at a glance#

ProductMenthol Cough Drops
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Temporarily relieves: Cough as may occur with a cold or inhaled irritants. Ocasional minor irritation and sore throat.

Dosage and administration

Adults and children 6 years and older: Disolve 1 drop slowly in the mouth. May be repeated every hour as needed. Children under 6 years: Use only under adult supervision.

Storage and handling

Contains: Soy

Label contents#

Full prescribing information#

Menthol Cough Drops

OTC - ACTIVE INGREDIENT SECTION

Menthol 5 mg Purpose: Cough suppressant.

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:

  • Cough as may occur with a cold or inhaled irritants.
  • Ocasional minor irritation and sore throat.

Warnings

WARNINGS SECTION

Sore throat warning if sore throat is severe, persists, for more than 2 days, is accompained or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. This symptoms may be serious.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

• Persistent or chronic cough such as occurs with smoking, asthma, or emphysema. • Cough accompained by excessive phlegm (mocus).

When using this product

OTC - WHEN USING SECTION

Do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Cough persists for more than 7 days, tends to recur, or is accompained by fever, rash, or persisstent headache. This could be signs of a serious condition.

Sore throat is severe, or irritation, pain or redness lasts or worsens.

If pregmant or breast-feeding Ask a health professional before use.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years and older: Disolve 1 drop slowly in the mouth. May be repeated every hour as needed.
  • Children under 6 years: Use only under adult supervision.

Other information

STORAGE AND HANDLING SECTION

Contains: Soy

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Anhydrous dextrose, citric acid monohydrate, cordia boissieri whole, eucalyptus globulus leaf, FD&C Blue No.1, honey, mint, myrrh, propolis wax, sambucus nigra flower, soy lecithin, sucrose, verbascum densiflorum flower. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Package Label - Menthol Drops

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MentholDrops NDC: 72432-200-01

MentholDropsMentholDrops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311508menthol 5 MG Oral LozengePSN3
311508menthol 5 MG Oral LozengeSCD3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72432-200-012023-01-30C16284748780-1f386c649-b550-0266-e053-dadaa90a7c1aMenthol Cough Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72432-200-01Menthol Cough Drops36 g in 1 BLISTER PACKPASTILLE363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72432-200MENTHOL COUGH DROPS (MENTHOL) PASTILLE [LA TIA TRINI SA DE CV]3Legacy NDC, 1 package rows20210731_c70507f3-b224-66e7-e053-2a95a90adeae.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72432-20072432-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
MENTHOLL7T10EIP3AACTIB
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
MYRRHJC71GJ1F3LIACT
MINTFV98Z8GITPIACT
PROPOLIS WAX6Y8XYV2NOFIACT
HONEYY9H1V576FHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
VERBASCUM DENSIFLORUM FLOWERN7FC535Q3RIACT
CORDIA BOISSIERI WHOLE57NZE56C0ZIACT
SUCROSEC151H8M554IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
c84b3037-dc58-2b0e-e053-2995a90aedd1c70507f3-b224-66e7-e053-2a95a90adeae2021-07-29WarningsExact identifier
spl id: c84b3037-dc58-2b0e-e053-2995a90aedd1
spl set id: c70507f3-b224-66e7-e053-2a95a90adeae

Reported adverse events (FAERS/openFDA)#

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