Label: EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT- menthol lozenge
- NDC Code(s): 54305-617-04, 54305-617-19, 54305-617-26
- 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
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54305-617 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) INVERT SUGAR (UNII: ED959S6ACY) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color green Score no score Shape OVAL Size 24mm Flavor MINT Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54305-617-19 19 in 1 BAG; Type 0: Not a Combination Product 05/27/2013 2 NDC:54305-617-26 26 in 1 BAG; Type 0: Not a Combination Product 05/27/2013 3 NDC:54305-617-04 4 in 1 PACKAGE; Type 0: Not a Combination Product 05/27/2013 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/27/2013 Labeler - Ricola Ag (480227248) Establishment Name Address ID/FEI Business Operations Ricola Ag 485393768 manufacture(54305-617)