COUGH DROPS- simply sugar free honey lemon pastille 
Perrigo Direct 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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Simply Sugar Free Honey Lemon Cough Drops

Active Ingredient

Uses temporarily relieves:

Uses temporarily relieves:

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Ask a doctor before use if you have

Stop use and consult a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

citric acid, eucalyptus oil, flavors, isomalt, stevia, turmeric (for color)

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Questions or comments: 1-833-552-1767

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COUGH DROPS 
simply sugar free honey lemon pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-594
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ISOMALT (UNII: S870P55O2W)  
STEVIA LEAF (UNII: 6TC6NN0876)  
TURMERIC (UNII: 856YO1Z64F)  
Product Characteristics
Coloryellow (Transparent) Scorescore with uneven pieces
ShapeOVALSize25mm
FlavorHONEY (Lemon) Imprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-594-0125 in 1 BAG; Type 0: Not a Combination Product09/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2023
Labeler - Perrigo Direct Inc. (076059836)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
Boston Nutraceutical Production SL468121064manufacture(50804-594) , label(50804-594) , pack(50804-594)

Revised: 9/2023
Document Id: 0696b10c-972a-9dcf-e063-6294a90a1034
Set id: 0696b0ff-7659-97ea-e063-6394a90af9a5
Version: 1
Effective Time: 20230930
 
Perrigo Direct Inc.