MOUNTAIN HERB SUGAR FREE WITH STEVIA

MOUNTAIN HERB SUGAR FREE WITH STEVIA

Drug Labeling and Warnings

Drug Details

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MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC- 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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MOUNTAIN HERB SUGAR FREE WITH STEVIA

Drug Facts

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

Menthol, 4.8 mg

Uses

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings

Sore throat warnings:

  • 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.  These may be serious,
  • do not use in children under 6 years of age unless directed by a doctor.

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.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep out of reach of children.


Directions

  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

  • excessive use may have a laxative effect
  • protect from heat and moisture
  • product may be useful for diabetics on the advice of a doctor

Exchange information:  2 Drops - FREE Exchange

7 Drops = 1 Fruit

Dietary exchanges based on Exchange Lists for Diabetes

©2008 American Diabetes Association, American Dietetic Association.

Inactive Ingredients

color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, rebaudioside a, sorbitol

Image of SFMountainHerbwStevia19ct.jpg

MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54305-185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
ISOMALT (UNII: S870P55O2W)  
SORBITOL (UNII: 506T60A25R)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
Product Characteristics
Colorbrown (DEER BROWN) Scoreno score
ShapeOVALSize24mm
FlavorMENTHOL (MOUNTAIN HERB) Imprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54305-185-1919 in 1 PACKAGE; Type 0: Not a Combination Product09/01/2015
2NDC: 54305-185-4545 in 1 PACKAGE; Type 0: Not a Combination Product09/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2015
Labeler - Ricola Ag (480227248)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag 485393768manufacture(54305-185)

Revised: 12/2017
 
Ricola Ag


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