FDA.reportPublic FDA data

CVS Watermelon Cough Drops

Manufacturer
Bestco, Inc.
Effective date
2020-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:42:14

Label at a glance#

ProductCVS Watermelon Cough
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

temporarily relieves: cough associated with a cold or inhaled irritants occasional minor irritation and sore throat

Dosage and administration

Adults and children 5 years and over: allow 2 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor. Children under 5 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant/Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

cough associated with a cold or inhaled irritants
occasional minor irritation and sore throat

Warnings

WARNINGS SECTION

Sore throat warning:

SPL UNCLASSIFIED SECTION

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These 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 accompanied by excessive phlegm (mucus)

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 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION


Adults and children 5 years and over: allow 2 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

Children under 5 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

10 calories per drop

Inactive ingredients

INACTIVE INGREDIENT SECTION

Artificial flavoring, beta caroten, FD&C BLUE NO. 1, glucose syrup, propylene glycol, sucrose and water. Soybean oil used as processing aid.

Questions?

OTC - QUESTIONS SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FrontFront

BackBack

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52642-31552642-315-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA CAROTENE01YAE03M7JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CORN SYRUP9G5L16BK6NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
SOYBEAN OIL241ATL177AIACT
STARCH, CORNO8232NY3SJIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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