55494-120 : Bonjesta Oral Tablet, Extended Release


NDC: 55494-120
Labeler: Duchesnay USA, Inc.
Product Type: Human Prescription Drug
Drug Name:  Bonjesta
Dosage Form: Oral Tablet, Extended Release
Application #: NDA209661
Rev. Date: 


Appearance:


Markings: D
Shapes:  Round
Colors:  Pink
Size (mm): 8
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 55494-120-10: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (55494‑120‑10)
  • 55494-120-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (55494‑120‑60)
  • 55494-120-99: 6 TABLET, EXTENDED RELEASE IN 1 BOTTLE (55494‑120‑99)

Active Ingredients:

  • Doxylamine Succinate
  • Pyridoxine Hydrochloride

Dosage Strength:

  • 20 mg
  • 20 mg

Inactive Ingredients:

  • Ammonia
  • Butyl Alcohol
  • Carnauba Wax
  • Silicon Dioxide
  • Croscarmellose Sodium
  • D&c Red No. 27
  • Alcohol
  • Ferrosoferric Oxide
  • Fd&c Blue No. 2
  • Hypromelloses
  • Ferric Oxide Red
  • Isopropyl Alcohol
  • Magnesium Stearate
  • Magnesium Trisilicate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 3350
  • Propylene Glycol
  • Shellac
  • Dimethicone
  • Sodium Bicarbonate
  • Sodium Lauryl Sulfate
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate /

Pharmaceutical Classes:

  • Antihistamine [EPC]
  • Histamine Receptor Antagonists [MoA]
  • Vitamin B6 Analog [EPC]
  • Vitamin B 6 [Chemical/Ingredient]
  • Analogs/Derivatives [Chemical/Ingredient]

NDC QR Code

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NDC 55494-120 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.