Home › NDC Lookup › Ingredients › Doxylamine Succinate And Pyridoxine Hydr... › 55494-0120-10
Bonjesta doxylamine succinate and pyridoxine hydrochloride 20 mg; 20 mg Tablet, Extended Release, 100-count — NDC 55494-0120-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bonjesta doxylamine succinate and pyridoxine hydrochloride 20 mg; 20 mg Tablet, Extended Release, 100-count — NDC 55494-120-10 (Billing 55494-0120-10)

by Duchesnay USA, Inc. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 tablets of Bonjesta doxylamine succinate and pyridoxine hydrochloride 20 mg; 20 mg Tablet, Extended Release from Duchesnay USA, Inc., marketed since Feb 2018 and currently FDA-listed.

NDC 55494-0120-10
🏷️ FDA NDC (as labeled) 55494-120-10 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Product page 55494-0120-60 Also comes in: 4 tablets 55494-120-94 6 tablets 55494-120-99 60 tablets 55494-120-60
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 55494-120-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55494 labeler · 120 product · 10 package
Package marketed since
Feb 19, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0355494120605
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Doxylamine Succinate And Pyridoxine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 7, 2026 — Presence of Foreign Tablets/Capsules (Bionpharma Inc.) · FDA recall D-0822-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55494-120-10
Product NDC 55494-120
11-digit billing NDC 55494012010
RxCUI 1999651, 1999657
UNII V9BI9B5YI2, 68Y4CF58BV
UPC 0355494120605
Application # NDA209661
SPL Set ID dba60bb4-54ff-4e06-b8d2-acbbd3717666
Established class (EPC) Antihistamine; Vitamin B6 Analog
Mechanism of action Histamine Receptor Antagonists
Chemical class Analogs/Derivatives; Vitamin B 6
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-19
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 50309902100430
GPI class Bonjesta
GCN Seq No 076841
GCN 42645
HICL code 001970
Ingredient (HICL) Doxylamine Succinate/Vit B6
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 48:04.04.00
AHFS class First Generation Antihist.(Respir Tract)
FDB label name BONJESTA ER 20-20 MG TABLET
FDB brand name Bonjesta
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 076841
  • GCN: 42645
  • GPI-14 (Medi-Span): 50309902100430
  • HICL (First Databank): 001970
  • AHFS class code: 48:04.04.00
  • RxCUI (RxNorm): 1999651
Why two NDCs? The FDA registers this code as 55494-120-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55494-0120-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Aminoalkyl ethers
How it works Histamine Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BONJESTA ER 20-20 MG TABLET Ingredient Doxylamine Succinate/Vit B6
📗 Our plain-language guide HelloPharmacist
  • It treats nausea and vomiting of pregnancy in women who have not improved with conservative management. It has not been studied in hyperemesis gravidarum.
  • Take it daily on an empty stomach with a glass of water, and swallow it whole. Don't crush, chew or split it. Take it every day rather than only when you feel sick, and follow your...
  • Sleepiness is the most common side effect. Avoid driving or operating heavy machinery until your provider says it's safe.
  • No. Alcohol and other sedating medicines can cause severe drowsiness, leading to falls or accidents. Never combine it with an MAO inhibitor.
📖 Read our full Doxylamine and Pyridoxine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 4 tablets 6 tablets 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
55494-0120-10 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE — — 2018-02-19 — Active
55494-0120-60 55494-120-60 Main listing 60 TABLET, EXTENDED RELEASE in 1 BOTTLE $11.12 / ea $666.92 2018-02-19 — Active
55494-0120-99 55494-120-99 6 TABLET, EXTENDED RELEASE in 1 BOTTLE Sample — — 2018-02-19 — Active
55494-0120-94 55494-120-94 1 BLISTER PACK in 1 CARTON / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK Sample — — 2025-02-26 — Active

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, extended release in 1 bottle.
How does this package differ from NDC 55494-0120-94?
Both are Bonjesta doxylamine succinate and pyridoxine hydrochloride 20 mg; 20 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 100-count one, while NDC 55494-0120-94 is the 4 tablets package.
What NDC number is used to bill for this package of Bonjesta doxylamine succinate and pyridoxine hydrochloride 20 mg; 20 mg Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bonjesta 20 mg/1; 20 mgthis 55494-0120-10 Duchesnay 100 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
First FDA approval
Nov 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 7, 2016 RLD RS ⏳ ~6.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9937132 — method of use (U-1382)
US 9375404 — method of use (U-1382)
US 9526703 — method of use (U-1382)
US 9089489 — method of use (U-1382)
2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 9937132 ↗ Method of use U-1382 Feb 18, 2033
US 9375404 ↗ Method of use U-1382 Feb 18, 2033
US 9526703 ↗ Method of use U-1382 Feb 18, 2033
US 9089489 ↗ Method of use U-1382 Feb 18, 2033
Common questions
Is there a generic version of BONJESTA ER 20-20 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BONJESTA ER 20-20 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color pink
ShapeRound
ImprintD
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Doxylamine and Pyridoxine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII C2E1CI501T
    Magnesium trisilicate is a mineral compound that acts as an antacid and absorbent in medicines. It helps neutralize stomach acid and can absorb moisture and gases, making it useful in tablets and powders.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

25 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDuchesnay USA, Inc.
Application holderDUCHESNAY INC
FDA applicationNDA209661 (NDA)
Labeler code55494
First marketedFeb 2018
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Duchesnay USA, Inc. labeler code 55494

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

1 INDICATIONS AND USAGE BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use BONJESTA has not been studied in women with hyperemesis gravidarum. BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B 6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

( 1 )

⏱️ Dosage and Administration 181 words ▾

2 DOSAGE AND ADMINISTRATION On Day 1, take one tablet at bedtime. On Day 2, if symptoms are not adequately controlled, the dose can be increased to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets daily, one in the morning and one at bedtime, as described in the full prescribing information. ( 2 )

2.1Dosage Information Initially, take one BONJESTA extended-release tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime.

The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water [ see Clinical Pharmacology (12.3) ]. Swallow tablets whole.

Do not crush, chew, or split BONJESTA tablets. Take daily and not on an as needed basis. Reassess the woman for continued need for BONJESTA as her pregnancy progresses.

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS BONJESTA extended-release tablets are pink, round, film coated tablets containing 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride, imprinted on one side with the pink image of a pregnant woman and a "D" on the other side. Extended-release tablets containing 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. ( 3 )

⛔ Contraindications 83 words ▾

4 CONTRAINDICATIONS BONJESTA is contraindicated in women with any of the following conditions: Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of BONJESTA [ see Drug Interactions (7.1) ] . Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation ( 4 ) Monoamine oxidase (MAO) inhibitors ( 4 , 7 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Somnolence: BONJESTA may cause somnolence. Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA until cleared to do so by a healthcare provider ( 5.1 ) Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended ( 5.1 ) Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction ( 5.2 ) Interference with urine drug screen: BONJESTA may interfere with urine screening for methadone, opiates and PCP ( 5.3 )

5.1Somnolence and Severe Drowsiness BONJESTA may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA until cleared to do so by their healthcare provider. BONJESTA use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol.

The combination may result in severe drowsiness leading to falls or accidents [ see Drug Interactions (7.1) ] .

5.2Concomitant Medical Conditions BONJESTA has anticholinergic properties and, therefore, should be used with caution in women with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.

5.3Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP) There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use [see Drug Interactions (7.3)].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: • Somnolence [ see Warnings and Precautions (5.1) ] • Falls or other accidents resulting from the effect of the combined use of BONJESTA with CNS depressants including alcohol [ see Warnings and Precautions (5.1) ] The most common adverse reaction (≥5 percent and exceeding the rate in placebo) with combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets is somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Duchesnay Inc. at 1-855-722-7734 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets compared to placebo was studied in a double-blind, randomized, multi-center trial in 261 women with nausea and vomiting of pregnancy.

The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation [ see Clinical Studies (14) ] . Adverse reactions that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1. Table 1: Number (Percent) of Women with ≥ 5 Percent Adverse Reactions in a 15-Day Placebo-Controlled Trial of Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence than Placebo are Shown) Adverse Reaction Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets (N = 133) Placebo (n = 128) Somnolence 19 (14.3%) 15 (11.7%)

6.2Postmarketing Experience The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure . Cardiac disorders : dyspnea, palpitation, tachycardia Ear and labyrinth disorders : vertigo Eye disorders : vision blurred, visual disturbances Gastrointestinal disorders : abdominal distension, abdominal pain, constipation, diarrhea General disorders and administration site conditions : chest discomfort, fatigue, irritability, malaise Immune system disorders : hypersensitivity Nervous system disorders : dizziness, headache, migraines, paresthesia, psychomotor hyperactivity Psychiatric disorders : anxiety, disorientation, insomnia, nightmares Renal and urinary disorders : dysuria, urinary retention Skin and subcutaneous tissue disorders : hyperhidrosis, pruritus, rash, rash maculopapular

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Severe drowsiness can occur when used in combination with alcohol or other sedating medications. ( 7 )

7.1Drug Interactions Use of BONJESTA is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with BONJESTA is not recommended.

7.2Drug-Food Interactions A food-effect trial demonstrated that the delay in the onset of action of BONJESTA may be further delayed, and a reduction in absorption may occur when tablets are taken with food [see Dosage and Administration (2) , Clinical Pharmacology (12.3) ] . Therefore, BONJESTA should be taken on an empty stomach with a glass of water [ see Dosage and Administration (2 )].

7.3False Positive Urine Tests for Methadone, Opiates and PCP False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use. Confirmatory tests, such as Gas Chromatography Mass Spectrometry (GC-MS), should be used to confirm the identity of the substance in the event of a positive immunoassay result.

7.1Drug Interactions Use of BONJESTA is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with BONJESTA is not recommended.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS BONJESTA is intended for use in pregnant women. ( 8.1 )

8.1Pregnancy Risk Summary BONJESTA is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women.

In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data ​Human Data The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride.

A second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination of doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.

8.2Lactation ​Risk Summary Women should not breastfeed while using BONJESTA. The molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk.

Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of BONJESTA resulting in worsening of their apnea or respiratory conditions. Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk.

8.4Pediatric Use The safety and effectiveness of BONJESTA in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. The overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest.

Children appear to be at a high risk for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3 year old child died 18 hours after ingesting 1,000 mg doxylamine succinate.

However, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.

🤰 Pregnancy 177 words ▾

8.1Pregnancy Risk Summary BONJESTA is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women.

In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data ​Human Data The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride.

A second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination of doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.

🧒 Pediatric Use 99 words ▾

8.4Pediatric Use The safety and effectiveness of BONJESTA in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. The overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest.

Children appear to be at a high risk for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3 year old child died 18 hours after ingesting 1,000 mg doxylamine succinate.

However, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.

🆘 Overdosage 94 words ▾

10 OVERDOSAGE

10.1Signs and Symptoms of Overdose BONJESTA is an extended-release formulation, therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.

10.2Management of Overdose If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. For additional information about overdose treatment, call a poison control center ( 1-800-222-1222 ).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of BONJESTA is unknown.

12.3Pharmacokinetics The pharmacokinetics of BONJESTA has been characterized in healthy non-pregnant adult women. Absorption In a single-dose, crossover clinical trial conducted in 48 healthy, premenopausal women under fasting conditions, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet was bioequivalent to two combination tablets of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride based on the exposure (AUC) and peak concentration (C max ) of doxylamine and baseline corrected pyridoxal 5′-phosphate.

Mean ± SD plasma (whole blood for pyridoxal) pharmacokinetic (PK) parameters are summarized in Table 2. Table 2 – Mean ± SD Single-Dose Pharmacokinetics of BONJESTA in Healthy Premenopausal Adult Women BONJESTA Mean±SD AUC 0-t (ng•h/mL) AUC 0-inf (ng•h/mL) AUC 0-72 (ng•h/mL) C max (ng/mL) T max Median (range) (h) Doxylamine N=48 1367.0 ± 356.7 1425.8 ± 405.1 --- 92.3 ± 15.7 4.5 (2.5-5.5) Pyridoxine N=47 42.3 ± 14.7 42.5 ± 14.7 --- 47.1 ± 18.7 0.5 (0.5-4.7) Pyridoxal Baseline corrected values N=48 N=46 for AUC 0-inf 203.7 ± 51.7 233.6 ± 55.9 --- 58.9 ± 17.0 3.0 (0.8-5.0) Pyridoxal 5′-Phosphate N=48 --- --- 1076.2 ± 382.2 30.1 ± 9.2 9.0 (3.0-16.0) In a multiple-dose, crossover clinical trial conducted in 31 healthy, premenopausal women, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet given twice daily for 11 days was bioequivalent to one combination tablet of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride given three times daily (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime), based on the exposure (AUC) and peak concentration (Cmax) of doxylamine and baseline corrected pyridoxal 5′-phosphate.

Mean ± SD plasma (whole blood for pyridoxal) PK parameters are summarized in Table 3. Table 3 – Mean ± SD Multiple-Dose (Day 11) Pharmacokinetic Parameters of BONJESTA (given twice daily) in Healthy Premenopausal Adult Women BONJESTA Mean±SD AUC 0-24 (ng•h/mL) AUC 0-12 (ng•h/mL) AUC 0-6 (ng•h/mL) C max (ng/mL) T max Median (range) (h) Doxylamine N=34 2879.4 ± 696.0 1573.2 ± 406.5 883.6 ± 228.5 173.6 ± 45.5 3.5 (1.0-20.0) Pyridoxine N=34 80.0 ± 22.7 46.3 ± 15.4 45.3 ± 16.3 48.2 ± 23.7 1.5 (0.3-16.5) Pyridoxal Baseline corrected values N=34 1511.3 ± 300.0 848.1 ± 183.6 647.2 ± 149.6 189.6 ± 48.3 3.0 (2.0-15.0) Pyridoxal 5′-Phosphate N=34 1742.3 ± 554.3 831.7 ± 274.5 426.2 ± 144.0 85.9 ± 26.2 15.0 (2.0-24.0) Food Effect In a single-dose, crossover clinical trial conducted in 23 healthy, premenopausal women, the administration of a high fat, high calorie meal delayed the absorption of doxylamine, pyridoxine, and pyridoxine metabolites.

This delay is associated with lower peak concentrations of doxylamine, pyridoxine, and pyridoxal. The extent of absorption for pyridoxine was decreased. The effect of food on the peak concentration and the extent of absorption of the pyridoxine component is more complex because the pyridoxine metabolites such as pyridoxal, pyridoxamine, pyridoxal 5′-phosphate, and pyridoxamine 5′-phosphate also contribute to the biological activity.

Food significantly reduces the bioavailability of pyridoxine, lowering its C max and AUC by approximately 67% and 37%, respectively, compared to fasting conditions. Similarly, food significantly reduces pyridoxal C max by approximately 46% compared to fasting conditions. In contrast, food did not affect pyridoxal 5′-phosphate Cmax and AUC.

Table 4 – Mean ± SD Pharmacokinetic Parameters of Doxylamine and Pyridoxine Metabolites Following a Single Dose Administration of BONJESTA Under Fed and Fasted Conditions in Healthy Premenopausal Adult Women BONJESTA N=23 AUC 0-t (ng•h/mL) AUC 0-inf (ng•h/mL) C max (ng/mL) T max Profile of Subject 20 was excluded , Median (range) (h) T 1/2el (h) Doxylamine Mean±SD Fasted 1273.7 ± 276.2 1321.9 ± 315.5 85.9 ± 10.6 3.5 (2.5-5.5) 11.9 ±

2.2Fed 1242.8 ± 254.0… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 12 words ▾

12.1Mechanism of Action The mechanism of action of BONJESTA is unknown.

📦 How Supplied / Storage and Handling 123 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How supplied BONJESTA extended-release tablets are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each pink, round, film-coated, extended-release tablet contains 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride, and is imprinted on one side with the pink image of a pregnant woman and a "D" on the other side. BONJESTA tablets are provided as follows: NDC 55494-120-60 Bottles of 60 NDC 55494-120-10 Bottles of 100

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

📋 Description ~1 min read ▾

11 DESCRIPTION BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side.

Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1).

The empirical formula is C 17 H 22 N 2 O • C 4 H 6 O 4 and the molecular mass is 388.46. The structural formula is: Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride Pyridoxine hydrochloride is a vitamin B 6 analog.

The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C 8 H 11 NO 3 • HCl and the molecular mass is 205.64. The structural formula is: Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether. structure-1 structure-2 Kosher Symbol Halal Symbol

💬 Information for Patients 148 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information ) Somnolence Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA until cleared to do so. Inform women of the importance of not taking BONJESTA with alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates and sleep aids because somnolence could worsen leading to falls or other accidents.

Interference with urine drug screening Inform women that use of BONJESTA may result in false positive urine drug screening for methadone, opiates and PCP. BONJESTA is a registered trademark of Duchesnay Inc. U.S.

Patent Nos. 9,089,489, 7,560,122, 9,375,404 & 9,526,703. Manufactured by: Duchesnay Inc.

950 boul. Michèle-Bohec Blainville, Québec Canada J7C 5E2 Distributed by: Duchesnay USA, Inc. Princeton, NJ 08540 Tel: 1-855-722-7734 Fax: 1-888-588-8508 www.duchesnayusa.com ©2018, Duchesnay Inc.

All rights reserved.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of BONJESTA has been characterized in healthy non-pregnant adult women. Absorption In a single-dose, crossover clinical trial conducted in 48 healthy, premenopausal women under fasting conditions, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet was bioequivalent to two combination tablets of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride based on the exposure (AUC) and peak concentration (C max ) of doxylamine and baseline corrected pyridoxal 5′-phosphate.

Mean ± SD plasma (whole blood for pyridoxal) pharmacokinetic (PK) parameters are summarized in Table 2. Table 2 – Mean ± SD Single-Dose Pharmacokinetics of BONJESTA in Healthy Premenopausal Adult Women BONJESTA Mean±SD AUC 0-t (ng•h/mL) AUC 0-inf (ng•h/mL) AUC 0-72 (ng•h/mL) C max (ng/mL) T max Median (range) (h) Doxylamine N=48 1367.0 ± 356.7 1425.8 ± 405.1 --- 92.3 ± 15.7 4.5 (2.5-5.5) Pyridoxine N=47 42.3 ± 14.7 42.5 ± 14.7 --- 47.1 ± 18.7 0.5 (0.5-4.7) Pyridoxal Baseline corrected values N=48 N=46 for AUC 0-inf 203.7 ± 51.7 233.6 ± 55.9 --- 58.9 ± 17.0 3.0 (0.8-5.0) Pyridoxal 5′-Phosphate N=48 --- --- 1076.2 ± 382.2 30.1 ± 9.2 9.0 (3.0-16.0) In a multiple-dose, crossover clinical trial conducted in 31 healthy, premenopausal women, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet given twice daily for 11 days was bioequivalent to one combination tablet of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride given three times daily (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime), based on the exposure (AUC) and peak concentration (Cmax) of doxylamine and baseline corrected pyridoxal 5′-phosphate.

Mean ± SD plasma (whole blood for pyridoxal) PK parameters are summarized in Table 3. Table 3 – Mean ± SD Multiple-Dose (Day 11) Pharmacokinetic Parameters of BONJESTA (given twice daily) in Healthy Premenopausal Adult Women BONJESTA Mean±SD AUC 0-24 (ng•h/mL) AUC 0-12 (ng•h/mL) AUC 0-6 (ng•h/mL) C max (ng/mL) T max Median (range) (h) Doxylamine N=34 2879.4 ± 696.0 1573.2 ± 406.5 883.6 ± 228.5 173.6 ± 45.5 3.5 (1.0-20.0) Pyridoxine N=34 80.0 ± 22.7 46.3 ± 15.4 45.3 ± 16.3 48.2 ± 23.7 1.5 (0.3-16.5) Pyridoxal Baseline corrected values N=34 1511.3 ± 300.0 848.1 ± 183.6 647.2 ± 149.6 189.6 ± 48.3 3.0 (2.0-15.0) Pyridoxal 5′-Phosphate N=34 1742.3 ± 554.3 831.7 ± 274.5 426.2 ± 144.0 85.9 ± 26.2 15.0 (2.0-24.0) Food Effect In a single-dose, crossover clinical trial conducted in 23 healthy, premenopausal women, the administration of a high fat, high calorie meal delayed the absorption of doxylamine, pyridoxine, and pyridoxine metabolites.

This delay is associated with lower peak concentrations of doxylamine, pyridoxine, and pyridoxal. The extent of absorption for pyridoxine was decreased. The effect of food on the peak concentration and the extent of absorption of the pyridoxine component is more complex because the pyridoxine metabolites such as pyridoxal, pyridoxamine, pyridoxal 5′-phosphate, and pyridoxamine 5′-phosphate also contribute to the biological activity.

Food significantly reduces the bioavailability of pyridoxine, lowering its C max and AUC by approximately 67% and 37%, respectively, compared to fasting conditions. Similarly, food significantly reduces pyridoxal C max by approximately 46% compared to fasting conditions. In contrast, food did not affect pyridoxal 5′-phosphate Cmax and AUC.

Table 4 – Mean ± SD Pharmacokinetic Parameters of Doxylamine and Pyridoxine Metabolites Following a Single Dose Administration of BONJESTA Under Fed and Fasted Conditions in Healthy Premenopausal Adult Women BONJESTA N=23 AUC 0-t (ng•h/mL) AUC 0-inf (ng•h/mL) C max (ng/mL) T max Profile of Subject 20 was excluded , Median (range) (h) T 1/2el (h) Doxylamine Mean±SD Fasted 1273.7 ± 276.2 1321.9 ± 315.5 85.9 ± 10.6 3.5 (2.5-5.5) 11.9 ±

2.2Fed 1242.8 ± 254.0 1281.4 ± 282.9 64.5 ± 15.2 6.5 (2.0-24.0) 12.7 ±

2.60Pyridoxine Mean±SD Fasted 34.7 ± 10.6 35.1 ±… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES There have been no efficacy and safety trials conducted with BONJESTA. A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets (a different formulation and dosage strength than BONJESTA) in the treatment of nausea and vomiting of pregnancy. Adult women 18 years of age or older and 7 to 14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to 14 days of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets or placebo.

Two tablets of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride were administered at bedtime on Day 1. If symptoms of nausea and vomiting persisted into the afternoon hours of Day 2, the woman was directed to take her usual dose of two tablets at bedtime that night and, beginning on Day 3, to take one tablet in the morning and two tablets at bedtime. Based upon assessment of remaining symptoms at her clinic visit on Day 4 (± 1 day), the woman may have been directed to take an additional tablet mid-afternoon.

A maximum of four tablets (one in the morning, one in the mid-afternoon and two at bedtime) were taken daily. Over the treatment period, 19% of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablet-treated women remained on 2 tablets daily, 21% received 3 tablets daily, and 60% received 4 tablets daily. The primary efficacy endpoint was the change from baseline at Day 15 in the Pregnancy Unique-Quantification of Emesis (PUQE) score.

The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). At baseline, the mean PUQE score was 9.0 in the 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets arm and 8.8 in the placebo arm. There was a 0.7 (95% confidence interval 0.2 to 1.2 with p-value 0.006) mean decrease (improvement in nausea and vomiting symptoms) from baseline in PUQE score at Day 15 with 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets compared to placebo (see Table 6).

Table 6 – Change from Baseline in the Primary Endpoint, Pregnancy Unique-Quantification of Emesis (PUQE) Score at Day 15. (Intent-to-Treat Population with Last-Observation Carried Forward) PUQE Score The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score incorporated the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). Baseline was defined as the PUQE score completed at the enrollment visit.

Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets N=131 Placebo N=125 Treatment Difference [95% Confidence Interval] Baseline Change from baseline at Day 15 9.0 ± 2.1 -4.8 ± 2.7 8.8 ± 2.1 -3.9 ± 2.6 -0.7 [-1.2, -0.2]

🧪 Nonclinical Toxicology 44 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenicity Two-year carcinogenicity studies in rats and mice have been conducted with doxylamine succinate. Doxylamine succinate is not likely to have human carcinogenic potential. The carcinogenic potential of pyridoxine hydrochloride has not been evaluated.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 41 words ▾

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenicity Two-year carcinogenicity studies in rats and mice have been conducted with doxylamine succinate. Doxylamine succinate is not likely to have human carcinogenic potential. The carcinogenic potential of pyridoxine hydrochloride has not been evaluated.

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert Patient Information BONJESTA (bonn jest ah) (doxylamine succinate and pyridoxine hydrochloride) extended-release tablets, for oral use What is BONJESTA? BONJESTA is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments. It is not known if BONJESTA is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum.

Women with this condition may need to be hospitalized. It is not known if BONJESTA is safe and effective in children under 18 years of age. Do not take BONJESTA if you: are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in BONJESTA.

See the end of this Patient Information leaflet for a complete list of ingredients in BONJESTA. take monoamine oxidase inhibitors (MAOIs). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate. Before taking BONJESTA, tell your healthcare provider about all of your medical conditions, including if you: have eye problems called increased intraocular pressure or narrow angle glaucoma. have a stomach problem called stenosing peptic ulcer or pyloroduodenal obstruction. have a bladder problem called urinary bladder-neck obstruction. are breastfeeding or plan to breastfeed.

BONJESTA can pass into your breast milk and may harm your baby. You should not breastfeed while using BONJESTA. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take BONJESTA? Talk to your healthcare provider about how much BONJESTA to take and when to take it. Take BONJESTA everyday as prescribed by your healthcare provider.

Do not stop taking BONJESTA without talking to your healthcare provider first. See the following schedule for the right way you should start taking BONJESTA: Start with 1 tablet by mouth at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 1 tablet each day at bedtime.

If you still have nausea and vomiting on Day 2, start taking 1 tablet in the morning and 1 tablet at bedtime each day. Do not take more than 2 tablets (1 in the morning and 1 at bedtime) each day. Take BONJESTA on an empty stomach with a glass of water.

Take BONJESTA tablets whole. Do not crush, chew, or break BONJESTA tablets before swallowing. If you cannot swallow BONJESTA tablets whole, tell your healthcare provider.

If you take too much BONJESTA (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, urination changes and build-up of fluid in the body. If you have these symptoms and they are severe, they may lead to death. If you take too much BONJESTA, call your poison control center at 1-800-222-1222.

What are the possible side effects of BONJESTA? BONJESTA may cause serious side effects, including drowsiness. Drowsiness is a common side effect when taking BONJESTA, but can also be severe: Do not drive, operate heavy machinery, or do other activities that need your full attention unless your healthcare provider says that you may do so.

Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take BONJESTA. Severe drowsiness can happen or become worse causing falls or accidents. BONJESTA may cause false positive urine drug screening test for methadone, opiates and PCP.

These are not all the possible side effects of BONJESTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BONJESTA? Store… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 10 words ▾

Warnings and Precautions, Concomitant Medical Conditions ( 5.2 ) 10/2022

📄 Package Label / Principal Display Panel 65 words ▾

Package/Label Display Panel Bottle Label-Outside Front Cover with Imprint Area for Lot & Expiry NDC 55494-120-60 Bonjesta ® (doxylamine succinate and pyridoxine hydrochloride) Extended-release tablets 20mg/20mg WARNING: Swallow tablets whole. Do not crush, chew, or split the tablets. 60 extended-release tablets DUCHESNAY Rx only Bottle Label – Inside Cover Bottle Label-Outside Front Cover with Imprint Area for Lot & Expiry Bottle Label – Inside Cover

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets55494-0120-60 7,976 Rx · $3,927,453
100 tablets this page55494-0120-10 No Medicaid data
6 tablets55494-0120-99 No Medicaid data
4 tablets55494-0120-94 No Medicaid data
Drug total (last 4 qtrs): 7,976 Rx · 348,138 units · $3,927,453 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Bonjesta — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Bonjesta. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$24.7K
Claims incl. refills
44
Beneficiaries
34
Spend / beneficiary
$727.23
Spend / claim
$561.95
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for BONJESTA (this brand).

Top reported reactions

Nausea17
Abortion Spontaneous12
Serotonin Syndrome10
Somnolence10
Vomiting10
Drug Ineffective For Unapproved Indication9
Foetal Exposure During Pregnancy8

Age at onset

Neonate1
Adult9

Reporter sex

152 reports
Male · 3%
Female · 97%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28 9
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Duchesnay USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 4 tablets (55494-0120-94), 6 tablets (55494-0120-99), 60 tablets (55494-0120-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Duchesnay USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55494-0100-10 · Duchesnay 55494-0580-18 · Duchesnay →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.