Label: HERBION NATURALS MINT COUGH DROPS- menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 44237-021-16 - Packager: Herbion Pakistan (Pvt) Ltd
- 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 January 1, 2015
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- GENERAL PRECAUTIONS
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HERBION NATURALS MINT COUGH DROPS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44237-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.5 mg in 2.5 Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) SUGARCANE (UNII: 81H2R5AOH3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS OIL (UNII: 2R04ONI662) GREATER GALANGAL (UNII: 7Y64R856MB) HYSSOPUS OFFICINALIS WHOLE (UNII: 0IQW001KPE) CORDIA SEBESTENA FLOWER (UNII: LM8F18O4OJ) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) DEXTROSE (UNII: IY9XDZ35W2) LONG PEPPER (UNII: 2NMG4EA7B1) JUSTICIA ADHATODA LEAF (UNII: HH159XOV81) Product Characteristics Color white Score no score Shape ROUND Size 17mm Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44237-021-16 2 in 1 CARTON 1 9 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2015 Labeler - Herbion Pakistan (Pvt) Ltd (645482936) Registrant - Herbion Pakistan (Pvt) Ltd (645482936) Establishment Name Address ID/FEI Business Operations Herbion Pakistan (Pvt) Ltd 645482936 manufacture(44237-021)