NATURAL LEMON MINT HERB THROAT DROPS

NATURAL LEMON MINT HERB THROAT DROPS

Drug Labeling and Warnings

Drug Details

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NATURAL LEMON MINT HERB 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.

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NATURAL LEMON MINT HERB THROAT DROPS

Drug Facts

Purpose

Oral anesthetic

Active Ingredient (in each drop)

Menthol, 1.5 mg

Uses

temporarily relieves occasional minor irritation and pain associated with:

  • sore mouth
  • sore throat

Warnings

Do not use

  • in children under 6 years of age unless directed by a doctor.

Stop use and ask a doctor if

  • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.
  • sore mouth symptoms do not improve in 7 days.

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

Store in a dry place

Inactive Ingredients

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

Image of LemonMint24ct.jpg

NATURAL LEMON MINT HERB THROAT DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63667-957
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Coloryellow (GOLDEN YELLOW) Scoreno score
ShapeOVALSize24mm
FlavorLEMON (LEMON MINT) Imprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63667-957-2424 in 1 BAG; Type 0: Not a Combination Product01/01/1942
2NDC: 63667-957-3030 in 1 BAG; Type 0: Not a Combination Product01/01/194201/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/1942
Labeler - Ricola USA Inc. (177265261)
Establishment
NameAddressID/FEIBusiness Operations
Ricola Ag480227248manufacture(63667-957)

Revised: 12/2017
 
Ricola USA Inc.


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