CVS Pharmacy Cough Relief Honey Lemon Flavor

CVS Pharmacy Cough Relief Honey Lemon Flavor

Drug Labeling and Warnings

Drug Details

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CVS PHARMACY COUGH RELIEF HONEY LEMON FLAVOR- dextromethorphan hydrobromide, menthol lozenge 
CVS Pharmacy, Inc.

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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CVS Pharmacy Cough Relief Honey Lemon Flavor

CVS Pharmacy Cough Relief Honey Lemon Flavor


Active ingredients (in each lozenge)Purpose
Dextromethorphan HBr 5 mgCough suppressant
Menthol 5 mgOral pain reliever

Uses

temporarily relieves these symptoms:

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

Warnings

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 in a child under 6 years of age.

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 contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor or dentist 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 signs of a 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 a Poison Control Center right away.

Directions

  • adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
  • children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
  • children under 6 years of age, do not use

Other information

  • tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
  • store at room temperature

Inactive ingredients

Corn syrup, FD C yellow 10, FD C yellow 6, glycerin, natural and artificial flavors, propylene glycol, sucralose and water. Soybean oil and corn starch use as processing aids.

Questions?

Or to report an adverse event call 1-800-245-2898. Monday-Friday 8AM to 4PM EST

CVS Pharmacy Cough Relief Honey Lemon Flavor, 16 Count (59779-064-16)

HoneyLemon

CVS PHARMACY COUGH RELIEF HONEY LEMON FLAVOR 
dextromethorphan hydrobromide, menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
SOYBEAN OIL (UNII: 241ATL177A)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize18mm
FlavorHONEY, LEMONImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-064-1616 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/19/2014
Labeler - CVS Pharmacy, Inc. (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Bestco, Inc.002149136manufacture(59779-064)

Revised: 5/2014
 
CVS Pharmacy, Inc.


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