Label: SUGAR FREE COUGH DROPS- menthol pastille
- NDC Code(s): 51316-014-01
- Packager: CVS Pharmacy
- 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 December 14, 2022
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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
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INGREDIENTS AND APPEARANCE
SUGAR FREE COUGH DROPS
menthol pastilleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-014 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 STEVIOL (UNII: 4741LYX6RT) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISOMALT (UNII: S870P55O2W) Product Characteristics Color white (Transparent) Score score with uneven pieces Shape OVAL Size 25mm Flavor MENTHOL Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-014-01 140 in 1 BAG; Type 0: Not a Combination Product 12/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/14/2022 Labeler - CVS Pharmacy (062312574) Registrant - Boston Nutraceutical Science SL (466061824) Establishment Name Address ID/FEI Business Operations Boston Nutraceutical Production SL 468121064 manufacture(51316-014) , label(51316-014) , pack(51316-014)