Benzocaine Dextromethorphan hydromimide

Drug Labeling and Warnings

Drug Details [pdf]

SORE THROAT AND COUGH LOZENGE- mixed berry lozenge 
Premier Value

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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Benzocaine
Dextromethorphan hydromimide

Active Ingredients (in each lozenge)

Benzocaine 7.5mg

Dextromethorphan hydrobromide 5mg

Oral Pain Reliever

Cough Suppressant

Uses temporarily relieves these symptoms:

• occasional minor mouth irritation, sore mouth and sore throat
• cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Allergy alert: Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine,benzocaine,

or other "caine" anestthetics.

Sore Throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash,

nausea or vomiting consult a doctor promptly.

Do not use if you are now taking a prescription 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 contrains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• persistent chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling develops
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These

could be a sign of serious illness

If pregnant or breast-feeding, ask a health professional before use.

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

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

Directions

adults and children 12 years and older

take 2 lozenges (one immediately after the other) and allow to dissolve slowly in mouth, may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor

children 6 to 12 years of age

take 1 lozenge and allow to dissolve in the mouth, may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours or as directed by a doctor

children 6 years of age

do not use

Other information

• store at room temperature
• protect from moisture

Inactive Ingredients:

Acesulfame potassim, corn syrup, FD&C Blue 1, FD&C Red 40, natuiral and artificial flavors

(medium chain triglycerides), propylene glycol, sucrose, and water. Soybean oil and corn starch used as processing aids.

Questions?

Or to report an adverse event call 1-800-245-2898, Monday through Friday, 9AM-4PM EST

SORE THROAT AND COUGH LOZENGE 
mixed berry lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-038
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-038-18	18 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/28/2015	08/01/2019

Labeler - Premier Value (101668460)

Registrant - Bestco, Inc (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco, Inc		002149136	manufacture(68016-038)

Revised: 10/2018

Document Id: 7899833e-32b8-1d75-e053-2991aa0a8691

34390-5

Set id: 464e48da-0aea-54be-e054-00144ff88e88

Version: 2

Effective Time: 20181019