Label: SUCRETS COMPLETE VAPOR CHERRY- dyclonine hydrochloride and menthol lozenge
Contains inactivated NDC Code(s)
NDC Code(s): 63736-920-18, 63736-920-24
- Packager: Insight Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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 August 4, 2009
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- Official Label (Printer Friendly)
- Active ingredient (per lozenge)
Sore throat warning
Severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, swelling and nausea may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor.
Ask a doctor before use if you have
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. These could be signs of a serious condition.
- Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 18 Lozenges Container
- PRINCIPAL DISPLAY PANEL - 24 Lozenges Container
- PRINCIPAL DISPLAY PANEL - Back Label
INGREDIENTS AND APPEARANCE
SUCRETS COMPLETE VAPOR CHERRY
dyclonine hydrochloride and menthol lozenge
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-920 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dyclonine Hydrochloride (UNII: ZEC193879Q) (Dyclonine - UNII:078A24Q30O) Dyclonine Hydrochloride 3 mg Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 6 mg Inactive Ingredients Ingredient Name Strength Corn Syrup (UNII: 9G5L16BK6N) Sucrose (UNII: C151H8M554) Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Citric Acid Monohydrate (UNII: 2968PHW8QP) Zinc Gluconate (UNII: U6WSN5SQ1Z) Tartaric Acid (UNII: W4888I119H) Sodium Ascorbate (UNII: S033EH8359) Acesulfame Potassium (UNII: 23OV73Q5G9) Ascorbic Acid (UNII: PQ6CK8PD0R) FD&C Red no. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score no score Shape ROUND Size 19mm Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-920-18 18 in 1 CANISTER 2 NDC:63736-920-24 24 in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/31/2009 Labeler - Insight Pharmaceuticals (176792315)