Label: SUGAR FREE HONEY-LEMON FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge
- NDC Code(s): 55711-071-01, 55711-071-02, 55711-071-03, 55711-071-04
- Packager: Lofthouse of Fleetwood, Ltd.
- 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 May 14, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each lozenge)
- Purpose
- Uses
-
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a 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 Doctor
Ask a doctor before use if you have • a cough that occurs with too much phlegm (mucus) • a persistent or chronic cough that lasts such as occurs with smoking, asthma, or emphysema.
Stop Use
Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. • sore throat is severe, lasts more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUGAR FREE HONEY-LEMON FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55711-071 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.52 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SORBITOL (UNII: 506T60A25R) ACESULFAME (UNII: MA3UYZ6K1H) CITRIC ACID ACETATE (UNII: DSO12WL7AU) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white (White lozenge with honey-colored spots) Score score with uneven pieces Shape OVAL (Oval lozenge 22mm x 13mm) Size 20mm Flavor LEMON (Honey-Lemon Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55711-071-01 2 in 1 PACKET; Type 0: Not a Combination Product 05/02/2019 2 NDC:55711-071-03 2 in 1 BAG 05/02/2019 2 20 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:55711-071-02 20 in 1 PACKET; Type 0: Not a Combination Product 05/02/2019 4 NDC:55711-071-04 2 in 1 BOX 05/02/2019 4 20 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/02/2019 Labeler - Lofthouse of Fleetwood, Ltd. (212605588) Establishment Name Address ID/FEI Business Operations Lofthouse of Fleetwood, Ltd. 212605588 manufacture(55711-071)
