ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE

ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE

Drug Labeling and Warnings

Drug Details

k">

SUGAR FREE MOUNTAIN HERB COUGH SUPPRESSANT THROAT DROPS- menthol lozenge 
Ricola USA 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.

----------

ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE

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.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

  • Phenylketonurics: contains phenylalanine 1 mg per drop
  • excessive use may have a laxative effect
  • store in a dry place
  • 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 Diabetics

© 2008 American Diabetes Association, American Dietetic Association

Inactive Ingredients

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

Image of SFOriginalSwissHerb19ct.jpg

SUGAR FREE MOUNTAIN HERB COUGH SUPPRESSANT THROAT DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63667-958
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
Inactive Ingredients
Ingredient NameStrength
ISOMALT (UNII: S870P55O2W)  
SORBITOL (UNII: 506T60A25R)  
ASPARTAME (UNII: Z0H242BBR1)  
CARAMEL (UNII: T9D99G2B1R)  
Product Characteristics
Colorbrown (DEER BROWN) Scoreno score
ShapeOVALSize24mm
FlavorMENTHOLImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63667-958-1919 in 1 BAG; Type 0: Not a Combination Product04/12/1942
2NDC: 63667-958-2424 in 1 BAG; Type 0: Not a Combination Product04/12/194212/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/12/1942
Labeler - Ricola USA Inc. (177265261)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag485393768manufacture(63667-958)

Revised: 12/2017
 
Ricola USA Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.