Label: DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC- menthol lozenge
- NDC Code(s): 54305-313-19, 54305-313-26, 54305-313-75
- Packager: Ricola Ag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each drop)
- Uses
- Warnings
- Ask doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54305-313 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8.3 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) MALIC ACID (UNII: 817L1N4CKP) Product Characteristics Color red Score no score Shape OVAL Size 24mm Flavor CHERRY Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54305-313-19 19 in 1 BAG; Type 0: Not a Combination Product 04/03/2011 2 NDC:54305-313-26 26 in 1 BAG; Type 0: Not a Combination Product 04/03/2011 3 NDC:54305-313-75 175 in 1 BAG; Type 0: Not a Combination Product 04/03/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/03/2011 Labeler - Ricola Ag (480227248) Establishment Name Address ID/FEI Business Operations Ricola Ag 485393768 manufacture(54305-313)