Sanatos Eucalyptus Lozenges (LP)

Manufacturer
Pharmadel LLC
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-04 03:32:29

Label at a glance#

ProductSanatos
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat cough as may occur with a cold

Dosage and administration

adults and children 4 years of age and older: dissolve (1) lozenge slowly in mouth repeat every 2 hours as needed or as directed by a doctor children under 4 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredient (in each lozenge) Purposes
Menthol 5.4 mg................................................Cough suppressant / oral anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of

  • occasional minor irritation, pain, sore mouth and sore throat
  • cough as may occur with a cold

Warnings

WARNINGS SECTION

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by high fever, headache, rash, nausea or vomiting, consult a doctor promptly. These may be serious.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • a cough that is 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

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persist or worsens
  • 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.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 4 years of age and older:
  • dissolve (1) lozenge slowly in mouth
  • repeat every 2 hours as needed or as directed by a doctor
  • children under 4 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store in cool dry place below 77ºF (25ºC)
  • protect from heat and light
  • do not use if package is torn or punctured

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, corn syrup, eucalyptus oil, FD&C blue #1, FD&C red #40, flavors, hypromellose, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist by/ por:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE 19720

Made in India/ Hecho en India

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Eucalyptus MintPDP Eucalyptus Mint

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-51855758-518-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
SanatosMENTHOLPharmadel LLC522e1e7f-98ed-c475-e063-6294a90a622c2026-07-16WarningsExact identifier
ndc (package): 55758-518-30
ndc (product): 55758-518
ndc11 (package): 55758051830
spl id: 56c15d5b-c5d5-a415-e063-6394a90a5fe1
spl set id: 522e1e7f-98ed-c475-e063-6294a90a622c

Reported adverse events (FAERS/openFDA)#

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