SUCRETS MS WINTERGREEN- dyclonine hydrochloride lozenge 
Insight Pharmaceuticals LLC

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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SUCRETS®

Drug Facts

Active ingredient (per lozenge)

Dyclonine Hydrochloride 3.0 mg

Purpose

Sore Throat/Oral Anesthetic

Uses

for the temporary relief of the following occasional mouth and throat symptoms:

  • pain
  • minor irritation
  • sore mouth
  • sore throat

Warnings

Stop use and ask a doctor if

  • sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting
  • sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges per day.
  • children under 6 years of age: ask a dentist or doctor.

Inactive ingredients

Citric Acid, Corn Syrup, D&C Yellow 10, Flavors, Menthol, Propylene Glycol, Purified Water, Sucrose, Titanium Dioxide.

Questions

Call 1-800-344-7239 or write to Consumer Affairs.

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

Visit us on the web at
www.insightpharma.com

PRINCIPAL DISPLAY PANEL - 18 Lozenges container

SAFETY SEALED: Do not use if foil imprinted with "Sucrets" is torn or missing

SUCRETS®
Dyclonine Hydrochloride • Sore Throat/Oral Anesthetic

Maximum Strength
SORE THROAT
Made Stronger To Last Longer! ®

18 SORE THROAT LOZENGES
WINTERGREEN

Principle Display Panel - 18 Lozenges container
SUCRETS  MS WINTERGREEN
dyclonine hydrochloride lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-915
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE3 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CORN SYRUP (UNII: 9G5L16BK6N)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (light green) Scoreno score
ShapeROUNDSize19mm
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-915-1818 in 1 BOX; Type 0: Not a Combination Product07/28/200908/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/28/200908/31/2017
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 7/2009
Document Id: 0683c696-2ef8-461b-9c9c-cc6bdafa951c
Set id: 6fde9446-0f8d-4bba-98dc-3e3a1f170488
Version: 3
Effective Time: 20090731
 
Insight Pharmaceuticals LLC