Label: BENZONATATE capsule, gelatin coated
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-763-20 - Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 51224-001
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 15, 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
- WARNINGS
- CONTRAINDICATIONS
- PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRODUCT PACKAGING
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INGREDIENTS AND APPEARANCE
BENZONATATE
benzonatate capsule, gelatin coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-763(NDC:51224-001) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color yellow Score no score Shape OVAL Size 11mm Flavor Imprint Code N01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-763-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202765 02/15/2016 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-763)
