Green Apple Cough Drops

Green Apple Cough Drops

Drug Labeling and Warnings

Drug Details

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GREEN APPLE COUGH DROPS- menthol, unspecified form lozenge 
CVS

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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Green Apple Cough Drops

Drug Facts

Active Ingredient (in each drop)

Menthol 2.6mg

Purpose

Cough suppressant/ Oral anesthetic

Uses

temporarly relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat

Warnings

Sore throat warning: ​If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have:

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

When using this product

  • do not exceed recommended dosage

Stop use and consult doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 5 years and over       allow 2 drops to dissolve slowly in mouth, one at a time.  May be repeated every two hours as   necessary or as directed by a doctor.
 children under 5 years   ask a doctor.

Other information

  • 10 calories per drop

Inactive ingredients

Beta carotene, citric acid, corn starch, eucalyptus oil, FD&C blue no. 1, glucose syrup, glycerin, medium chain triglycerides, natural flavor, soybean oil, sucrose and water. May contain these ingredients. 

Questions?

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

Package Labeling:

label

GREEN APPLE COUGH DROPS 
menthol, unspecified form lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-639
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.6 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STARCH, CORN (UNII: O8232NY3SJ)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CORN SYRUP (UNII: 9G5L16BK6N)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
Product Characteristics
Colorgreen (Green) Scoreno score
ShapeOVAL (Oval) Size22mm
FlavorAPPLE (Green Apple) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-639-301 in 1 CARTON
130 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/09/2015
Labeler - CVS (062312574)

Revised: 11/2015
 
CVS


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