Skip to Content

Sore throat and cough lozenge

Dosage form: lozenge
Labeler: Premier Value
NDC Code: 68016-038

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.

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


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.


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.


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

mixed berry lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-038
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
Product Characteristics
ColorredScorescore with uneven pieces
FlavorBERRY (mixed) Imprint CodeB
#Item CodePackage Description
1NDC:68016-038-1818 LOZENGE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/28/201508/01/2019
Labeler - Premier Value (101668460)
Registrant - Bestco, Inc (002149136)
Bestco, Inc002149136manufacture(68016-038)

Premier Value

Medically reviewed on Oct 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.