PV-MGC-YNBY Cough Drops Menthol 30

Manufacturer
Pharmacy Value Alliance LLC | Medical Group Care LLC
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:27:38

Label at a glance#

ProductPremier Value
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. ■ children under 5 years: ask a doctor.

Storage and handling

■ 10 calories per drop ■ contains: SOY.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.4 mg

Purpose

OTC - PURPOSE SECTION

Purposes cough suppressant, oral anesthetic

Use

INDICATIONS & USAGE SECTION

temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

Warnings

WARNINGS SECTION

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These 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 a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

■ 10 calories per drop ■ contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glucose syrup, sucralose, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, potassium citrate, sucrose, soy lecithin, water

OTC - QUESTIONS SECTION

Or, to report an adverse event, call 800-245-2898.
Monday - Friday, 9 AM to APM EST

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PV labelPV label30 Drops NDC: 68016-885-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
485287menthol 5.4 MG Oral LozengePSN3
485287menthol 5.4 MG Oral LozengeSCD3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-885-30Premier Value5.4 in 1 BAGLOZENGE5.43

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-88568016-885-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Premier ValueCOUGH DROPS MENTHOLPharmacy Value Alliance LLC019211bf-dd4b-5f4c-e063-6294a90aacfb2025-12-22WarningsExact identifier
ndc (package): 68016-885-30
ndc (product): 68016-885
ndc11 (package): 68016088530
spl id: 468e78a5-7a98-6efb-e063-6394a90aba2b
spl set id: 019211bf-dd4b-5f4c-e063-6294a90aacfb

Reported adverse events (FAERS/openFDA)#

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