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Sore throat and cough lozenge by Premier Value

Medically reviewed on January 17, 2017

Dosage form: lozenge
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg, BENZOCAINE 7.5mg
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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-038
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorredScorescore with uneven pieces
ShapeROUNDSize17mm
FlavorBERRY (mixed) Imprint CodeB
Contains    
Packaging
#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 finalpart35607/28/2015
Labeler - Premier Value (101668460)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc002149136manufacture(68016-038)

 
Premier Value

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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