THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS

THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS

Drug Labeling and Warnings

Drug Details

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THE ORIGINAL NATURAL HERB COUGH 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.

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THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS

Drug Facts

Purpose

Cough suppressant, Oral pain reliever

Active Ingredient (in each drop)

Menthol, 5.3 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 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

Inactive Ingredients

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

Image of STG_ETGD_RKZ_37G_US_9008618_Final.jpg

THE ORIGINAL NATURAL HERB COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63667-923
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.3 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
CARAMEL (UNII: T9D99G2B1R)  
Product Characteristics
Colorbrown (NUT BROWN) Scoreno score
ShapeRECTANGLESize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63667-923-1010 in 1 PACKAGE; Type 0: Not a Combination Product01/01/1942
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1942
Labeler - Ricola USA Inc. (177265261)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag485393768manufacture(63667-923)

Revised: 12/2017
 
Ricola USA Inc.


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