Label: THROAT BALM CARAMEL PECTIN- pectin lozenge
- NDC Code(s): 54305-301-34
- Packager: Ricola Ag
- 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 January 18, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients: Caramel sugar syrup; cocoa butter; emulsifier (sunflower lecithin), extracts of bee balm, Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme) and rooibos; glucose syrup; glucose-fructose syrup; honey; humectant (glycerine); natural flavoring (caramel, echinacea purpurea fresh plant pressed juice powder, honey, menthol, peppermint, vanilla); salt; sugar
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INGREDIENTS AND APPEARANCE
THROAT BALM CARAMEL PECTIN
pectin lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54305-301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 3.8 mg Inactive Ingredients Ingredient Name Strength SUCROSE CARAMEL (UNII: D8GMM4517Q) Product Characteristics Color brown Score no score Shape OVAL Size 24mm Flavor CARAMEL Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54305-301-34 34 in 1 BAG; Type 0: Not a Combination Product 11/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/01/2022 Labeler - Ricola Ag (480227248) Establishment Name Address ID/FEI Business Operations Ricola Ag 485393768 manufacture(54305-301)