Label: PROMETHAZINE HYDROCHLORIDE tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 61919-630-60 - Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 57664-108
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 22, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- STORAGE
- PATIENT INFORMATION LEAFLET
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-630(NDC:57664-108) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (WHITE TO OFF WHITE) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 108 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-630-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040863 02/18/2016 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-630)
