Sanatos Lozenges by Pharmadel LLC SanaTos EX Lozenges

Sanatos Lozenges by

Drug Labeling and Warnings

Sanatos Lozenges by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANATOS LOZENGES EX- benzocaine, dextromethorphan hbr lozenge 
Pharmadel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SanaTos EX Lozenges

Drug Facts

Active ingredients & Purposes

• Active ingredients (in each lozenge): Purposes
• Benzocaine 7.5 mg: Oral anesthetic/ analgesic
• Dextromethorphan HBr 5 mg: Cough suppressant

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

Warnings

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:

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:

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

• 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

• 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

• 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.

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

Directions

• 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

Other 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

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

Questions & comments?

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

Principal Display Panel

SANATOS LOZENGES  EX
benzocaine, dextromethorphan hbr lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-328
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ISOMALT (UNII: S870P55O2W)
WATER (UNII: 059QF0KO0R)
MALTITOL (UNII: D65DG142WK)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	ROUND	Size	17mm
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-328-18	18 in 1 BOX; Type 0: Not a Combination Product	08/21/2020	09/29/2021
2	NDC: 55758-328-06	6 in 1 CARTON	08/24/2020	09/29/2021
2	NDC: 55758-328-18	18 in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/21/2020	09/29/2021

Labeler - Pharmadel LLC (030129680)

Revised: 9/2021

Document Id: cd2a84f0-e8e6-12f2-e053-2a95a90a70a4

34390-5

Set id: ad66bad7-d3a6-0c8d-e053-2a95a90ab2f4

Version: 2

Effective Time: 20210929