FDA.reportPublic FDA data

Sanatos Lozenges

Manufacturer
Pharmadel LLC
Effective date
2020-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:02:14

Label at a glance#

ProductSanatos Lozenges EX
Active ingredientBENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Indications and uses

For the temporary relief of occasional minor irritation sore throat sore mouth cough as may occur with a cold pain associated with canker sores

Dosage and administration

dissolve the lozenges slowly in the mouth. May repeat every 4 hours as needed or as direected by doctor. Age Dose adult and childrens 12 years and over take 2 lozenges children 2 to 12 years age take 1 lozenge children under 2 years of age do not use

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each lozenge)Purposes
Benzocaine 7.5 mgOral anesthetic/ analgesic
Dextromethorphan HBr 5 mgCough suppressant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of occasional

  • minor irritation
  • sore throat
  • sore mouth
  • cough as may occur with a cold
  • pain associated with canker sores

Warnings

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serous condition that must be treated promptly because it reduces the amount of oygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy alert:

WARNINGS SECTION

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

Sore throat warning:

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • if you are taking a perscription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains as MAOI, asl a doctor or pharmacist before taking this product.
  • do not use for teething
  • in children under 2 years of age

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 (mucus0

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 presistent headache. These could signs of a serious condiotion.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an overdose, get medical help or contact Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dissolve the lozenges slowly in the mouth. May repeat every 4 hours as needed or as direected by doctor.
AgeDose
adult and childrens 12 years and overtake 2 lozenges
children 2 to 12 years agetake 1 lozenge
children under 2 years of agedo not use

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

bicarbonate, FD&C blue 1, FD&C red 40, flavor, isomalt, maltitol, water.

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 LozengesSanatos Lozenges

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-32855758-328-18, 55758-328-06

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
SUCRALOSE96K6UQ3ZD4IACT
SODIUM BICARBONATE8MDF5V39QOIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOMALTS870P55O2WIACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
MALTITOLD65DG142WKIACT
FD&C RED NO. 40WZB9127XOAIACT

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
cd2a84f0-e8e6-12f2-e053-2a95a90a70a4ad66bad7-d3a6-0c8d-e053-2a95a90ab2f42021-09-29WarningsExact identifier
spl set id: ad66bad7-d3a6-0c8d-e053-2a95a90ab2f4

Reported adverse events (FAERS/openFDA)#

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