Label: COUGH DROPS- menthol pastille
- NDC Code(s): 83455-201-01
- Packager: United Natural Foods, Inc.
- 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 12, 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COUGH DROPS
menthol pastilleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83455-201 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 STEVIA LEAF (UNII: 6TC6NN0876) ISOMALT (UNII: S870P55O2W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color yellow (Transparent) Score score with uneven pieces Shape OVAL Size 25mm Flavor HONEY (Lemon) Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83455-201-01 200 in 1 BAG; Type 0: Not a Combination Product 05/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/12/2023 Labeler - United Natural Foods, Inc. (943556183) Registrant - Boston Nutraceutical Science SL (466061824) Establishment Name Address ID/FEI Business Operations Boston Nutraceutical Production SL 468121064 manufacture(83455-201) , label(83455-201) , pack(83455-201)