DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

Drug Labeling and Warnings

Drug Details

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DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC- 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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DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC

Drug Facts

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

Menthol, 8.3 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
  • do not bite or chew

Other Information

protect from heat and moisture

Inactive Ingredients

citric acid, extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, honey, lemon juice concentrate, natural color (beta-carotene), natural flavors, starch syrup, sugar

Image of DualActHoneyLem19ct.jpg

DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63667-234
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)  
HONEY (UNII: Y9H1V576FH)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize24mm
FlavorHONEYImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63667-234-1919 in 1 PACKAGE; Type 0: Not a Combination Product05/01/2015
2NDC: 63667-234-2626 in 1 PACKAGE; Type 0: Not a Combination Product05/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2015
Labeler - Ricola USA Inc. (177265261)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag 485393768manufacture(63667-234)

Revised: 12/2017
 
Ricola USA Inc.


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