Label: SUGAR FREE MENTHOL COUGH DROPS- menthol lozenge
- NDC Code(s): 41520-020-25
- Packager: American Sales
- 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.
Updated October 20, 2021
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
Inactive ingredients: Acesulfame potassium (non-nutritive sweetener), corn starch, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, hydrogenated starch hydrolysate, isomalt, medium chain triglycerides, natural and artificial flavors, potassium sorbate, soybean oil, sucralose (non-nutritive sweetener) and water.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
SUGAR FREE MENTHOL COUGH DROPS
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.8 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color blue (light blue with blue flakes) Score no score Shape OVAL Size 16mm Flavor MENTHOL Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-020-25 25 in 1 BAG; Type 0: Not a Combination Product 06/22/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/22/2016 Labeler - American Sales (809183973) Registrant - Bestco Inc. (002149136) Establishment Name Address ID/FEI Business Operations Bestco Inc. 002149136 manufacture(41520-020)