Label: MENTHOL VAPOR COUGH DROPS- menthol pastille
- NDC Code(s): 72628-108-01
- Packager: BOSTON NUTRACEUTICAL PRODUCTION, S.L
- 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 February 6, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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INGREDIENTS AND APPEARANCE
MENTHOL VAPOR COUGH DROPS
menthol pastilleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72628-108 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 20 mg Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) CORN SYRUP (UNII: 9G5L16BK6N) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ACACIA (UNII: 5C5403N26O) Product Characteristics Color blue (Clear with internal blue glitter) Score score with uneven pieces Shape OVAL Size 25mm Flavor MENTHOL (and eucalyptus) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72628-108-01 45 in 1 BAG; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2020 Labeler - BOSTON NUTRACEUTICAL PRODUCTION, S.L (468121064) Registrant - Boston Nutraceutical Science SL (466061824) Establishment Name Address ID/FEI Business Operations BOSTON NUTRACEUTICAL PRODUCTION, S.L 468121064 manufacture(72628-108) , label(72628-108)