FDA.reportPublic FDA data

Sanatos Lozenges

Manufacturer
Pharmadel LLC
Effective date
2019-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:28:38

Label at a glance#

ProductSanatos Lozenges
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor irritation and sore throats cough as may occur with a cold

Dosage and administration

adult and children 3 to under 12 years of age: allow the lozenge to dissolve one (1) drop slowly in mouth repeat every 2 hours as needed or as directed by doctor children under 3 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each lozenge) Purposes
Menthol 5.5 mg................................................ Cough suppressant / oral anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of

  • minor irritation and sore throats
  • 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

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • a cough that is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • a 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.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult and children 3 to under 12 years of age: allow the lozenge to dissolve one (1) drop slowly in mouth
  • repeat every 2 hours as needed or as directed by doctor
  • children under 3 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store in cool dry place below 77º F
  • protect from heat and light
  • do not use if package is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, citric acid monohydrate, cordia dichotoma fruit, corn syrup, eucalyptus oil, hyssopus officinalis flowering top, greater galangal, justicia adhatoda leaf, licorice, long pepper, natural orange flavor, sucrose.

Questions & comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaTos®

Sore Throat Lozenges/Pastillas para el dolor de garganta

Relieves Cough/Alivia la Tos

Soothes Sore Throats/Calma Dolor de Gargantas

Orange Flavor/Sabor a Naranja

5 pouches x 25 Lozenges each/5 bolsas x 25 pastillas cada una

Sanatos Lozenges OrangeSanatos Lozenges Orange

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
55758-30355758-303-25, 55758-303-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS OIL2R04ONI662IACT
JUSTICIA ADHATODA LEAFHH159XOV81IACT
HYSSOPUS OFFICINALIS FLOWERING TOPX7HKN4FOJIIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CORN SYRUP9G5L16BK6NIACT
GREATER GALANGAL7Y64R856MBIACT
SUCROSEC151H8M554IACT
MENTHOLL7T10EIP3AACTIB
CORDIA DICHOTOMA FRUITR4RI8646ZRIACT
LICORICE61ZBX54883IACT
LONG PEPPER2NMG4EA7B1IACT

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
cd2a9781-a23b-40a5-e053-2995a90ae400853ef35c-1d49-5f9d-e053-2a91aa0a49ff2021-09-29WarningsExact identifier
spl set id: 853ef35c-1d49-5f9d-e053-2a91aa0a49ff

Reported adverse events (FAERS/openFDA)#

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