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EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT

Medically reviewed on December 27, 2017

Dosage form: lozenge
Ingredients: MENTHOL 8.3mg
Labeler: Ricola USA Inc.
NDC Code: 63667-503

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.

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

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-503
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL8.3 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
GLYCERIN 
INVERT SUGAR 
PEPPERMINT 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize24mm
FlavorMINTImprint CodeR
Contains    
Packaging
#Item CodePackage Description
1NDC:63667-503-1919 LOZENGE in 1 BAG
2NDC:63667-503-2626 LOZENGE in 1 BAG
3NDC:63667-503-044 LOZENGE in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/27/2013
Labeler - Ricola USA Inc. (177265261)
Establishment
NameAddressID/FEIOperations
Ricola Ag 485393768manufacture(63667-503)

 
Ricola USA Inc.

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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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