EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT

Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT - menthol lozenge 
Ricola Ag

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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EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT

Drug Facts

Purpose

Cough suppressant

Active Ingredient (in each drop)

Menthol, 8.3 mg

Uses

temporarily relieves:

  • cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants

Warnings

Ask doctor before use if you have

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

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition

Keep out of reach of children.


Directions

  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

Store in a dry place

Inactive Ingredients

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

Image of ExtraStrGlacierMint19ct.jpg

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54305-617
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.3 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
GLYCERIN (UNII: PDC6A3C0OX)  
INVERT SUGAR (UNII: ED959S6ACY)  
PEPPERMINT (UNII: V95R5KMY2B)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize24mm
FlavorMINTImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54305-617-1919 in 1 BAG; Type 0: Not a Combination Product05/27/2013
2NDC: 54305-617-2626 in 1 BAG; Type 0: Not a Combination Product05/27/2013
3NDC: 54305-617-044 in 1 PACKAGE; Type 0: Not a Combination Product05/27/201301/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/27/2013
Labeler - Ricola Ag (480227248)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag 485393768manufacture(54305-617)

Revised: 12/2017
 
Ricola Ag


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