Label: NATURAL HERBAL COUGH DROPS- menthol pastille
- NDC Code(s): 72628-111-01
- 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
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WARNINGS
Warnings
Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious
- 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
NATURAL HERBAL COUGH DROPS
menthol pastilleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72628-111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.8 mg Inactive Ingredients Ingredient Name Strength LEMON BALM OIL (UNII: MJ76269K9S) PEPPERMINT (UNII: V95R5KMY2B) HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI) SAGE (UNII: 065C5D077J) THYME (UNII: CW657OBU4N) WILD THYME (UNII: KXK6I80R8W) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) CARAMEL (UNII: T9D99G2B1R) HOREHOUND (UNII: K08036XEJV) SUCROSE (UNII: C151H8M554) MALVA NEGLECTA WHOLE (UNII: S0QQA41760) CORN SYRUP (UNII: 9G5L16BK6N) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) Product Characteristics Color brown (dark) Score score with uneven pieces Shape OVAL Size 25mm Flavor MENTHOL (and herbal) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72628-111-01 50 in 1 BAG; Type 0: Not a Combination Product 05/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/12/2021 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(72628-111) , label(72628-111)