SANATOS LOZENGES EX- benzocaine, dextromethorphan hbr lozenge

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Available from:
Pharmadel LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of occasional - minor irritation - sore throat - sore mouth - cough as may occur with a cold - pain associated with canker sores
Authorization status:
OTC monograph not final
Authorization number:
55758-328-06, 55758-328-18

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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

Dos e

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55758 -328

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

7.5 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

5 mg

Pharmadel LLC

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

ISO MALT (UNII: S8 70 P55O2W)

WATER (UNII: 0 59 QF0 KO0 R)

MALTITO L (UNII: D6 5DG142WK)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

re d

S core

sco re with uneven pieces

S hap e

ROUND

S iz e

17mm

Flavor

BERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55758 -328 -18

18 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 20

2

NDC:55758 -328 -0 6

6 in 1 CARTON

0 8 /24/20 20

2

NDC:55758 -328 -18

18 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 8 /21/20 20

Labeler -

Pharmadel LLC (030129680)

Revised: 8/2020

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