Label: SUCRETS SORE THROAT WILD CHERRY- dyclonine hydrochloride lozenge
- NDC Code(s): 63736-560-18
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 4, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients (per lozenge)
- Purpose
- Uses
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Warnings
Sore through warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUCRETS SORE THROAT WILD CHERRY
dyclonine hydrochloride lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-560 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MENTHOL (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCROSE (UNII: C151H8M554) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score no score Shape ROUND Size 19mm Flavor CHERRY (Wild Cherry) Imprint Code S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-560-18 18 in 1 CONTAINER; Type 0: Not a Combination Product 07/28/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 07/28/2009 Labeler - Insight Pharmaceuticals LLC (055665422)