Doxylamine and Pyridoxine
Doxylamine and pyridoxine is a combination of an antihistamine and a vitamin B6 form, used to treat nausea and vomiting of pregnancy in women who do not respond to conservative management.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Doxylamine and Pyridoxine: Patient Information Guide
A plain-language walkthrough of Doxylamine and Pyridoxine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Doxylamine and Pyridoxine is used for
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This combination treats one condition across its supported products.
- Nausea and vomiting of pregnancy in women who do not respond to conservative management (Diclegis, Bonjesta and generic delayed-release tablets).
- Not studied in women with hyperemesis gravidarum.
How Doxylamine and Pyridoxine works
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The product combines an antihistamine (doxylamine succinate) with a vitamin B6 analog (pyridoxine hydrochloride). The exact mechanism of action is unknown.
How Doxylamine and Pyridoxine is taken (dosage)
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These are oral tablets taken daily on an empty stomach with a glass of water. Swallow them whole.
- Diclegis and the generic delayed-release tablets: usually begin with two tablets at bedtime. Your prescriber may add a morning and mid-afternoon tablet if symptoms persist.
- Bonjesta (extended-release): begins with one tablet at bedtime, and may be increased to a morning and a bedtime tablet.
- Take it daily, not as needed. Your need for it will be reassessed as pregnancy progresses.
Follow your prescriber and product label for exact directions.
Doxylamine and Pyridoxine side effects in detail
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The most common side effect is sleepiness. Other reactions reported after approval include:
- Sleepiness
- Dizziness and headache
- Constipation, diarrhea and abdominal pain
- Blurred vision
- Fatigue and irritability
- Insomnia and anxiety
Seek help for severe drowsiness with falls, allergic reactions, a fast or pounding heartbeat, or difficulty urinating.
Doxylamine and Pyridoxine warnings and precautions
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- Drowsiness: avoid driving or operating heavy machinery until your provider clears you.
- Alcohol and other CNS depressants: not recommended, since severe drowsiness can lead to falls or accidents.
- Drying effects: use caution with increased eye pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or bladder-neck obstruction.
- Urine drug screens: false positives for methadone, opiates and PCP can occur.
Doxylamine and Pyridoxine interactions: what it interacts with
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Several substances can clash with this medicine.
- MAO inhibitors: contraindicated because they prolong and intensify its drying effects.
- Alcohol: raises the risk of severe drowsiness.
- Sedatives and tranquilizers: not recommended together.
- Food: can delay and reduce absorption.
- Urine tests for methadone, opiates and PCP: may give false positives.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Doxylamine and Pyridoxine
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- Do not use with a known allergy to doxylamine, other ethanolamine antihistamines, pyridoxine or inactive ingredients.
- Do not use with MAO inhibitors.
- Tell your prescriber about glaucoma, stomach ulcer or blockage, or bladder-neck obstruction.
- Pregnancy: it is intended for use in pregnant women. Epidemiologic studies have reported no increased risk of congenital malformations.
- Breastfeeding: do not breastfeed while using it.
- Children under 18: safety and effectiveness have not been established.
Doxylamine and Pyridoxine overdose: if you take too much
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Symptoms may not appear right away because of the delayed-release design. They can include restlessness, dry mouth, dilated pupils, sleepiness, vertigo, confusion and a fast heartbeat. At toxic doses, seizures, muscle breakdown, kidney failure and death can occur. Call poison control at 1-800-222-1222.
Pharmacokinetics: how your body processes Doxylamine and Pyridoxine
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In healthy non-pregnant women, doxylamine and pyridoxine are absorbed in the gut, mainly in the jejunum. Peak levels of doxylamine and pyridoxine come within about 7.5 and 5.5 hours, respectively. Doxylamine builds up with repeated dosing. Food delays absorption and lowers pyridoxine levels, which is why it is taken on an empty stomach.
How to store Doxylamine and Pyridoxine
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Store at 20° to 25°C (68° to 77°F) . protect from moisture.
📄 Written from Doxylamine and Pyridoxine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Doxylamine and Pyridoxine
46 supplements and herbal products have documented interactions with Doxylamine and Pyridoxine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 32
- Minor · 11
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Doxylamine and Pyridoxine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Doxylamine and Pyridoxine — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take it?
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Will it make me sleepy?
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Can I drink alcohol or take sleep aids with it?
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Is it okay while breastfeeding?
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Could it affect a urine drug test?
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Is Doxylamine and Pyridoxine available over the counter?
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When was Doxylamine and Pyridoxine first available?
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Who makes Doxylamine and Pyridoxine?
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💬 Answers drafted from Doxylamine and Pyridoxine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Doxylamine and Pyridoxine on HelloPharmacist
💊 Doxylamine and Pyridoxine forms and strengths (how it comes)
Doxylamine and Pyridoxine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Delayed-release tablet
How this form is used
- Diclegis is used for nausea and vomiting of pregnancy in women who do not respond to conservative management.
- Generic doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are used for the same purpose.
- Diclegis starts with two tablets at bedtime, and your prescriber may increase to a maximum of four tablets daily.
- Diclegis is taken on an empty stomach with water, swallowed whole.
- Diclegis is taken daily, not as needed.
Extended-release tablet
How this form is used
- Bonjesta is used for nausea and vomiting of pregnancy in women who do not respond to conservative management.
- Bonjesta starts with one tablet at bedtime, and may be increased to one in the morning and one at bedtime.
- Bonjesta is taken on an empty stomach with water, swallowed whole.
- Bonjesta is taken daily, not as needed.
📊 Doxylamine and Pyridoxine on the U.S. market: products, makers and brands
How Doxylamine and Pyridoxine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Doxylamine and Pyridoxine is used (Medicaid data)
A general measure of how commonly Doxylamine and Pyridoxine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Doxylamine and Pyridoxine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Doxylamine and Pyridoxine prescribed? Of the 1,599 medications we measure, Doxylamine and Pyridoxine ranks #516 by Medicaid prescriptions — more than 68% of them.
Utilization by Doxylamine and Pyridoxine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet Most dispensed
Summed across the 6 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1375948
12 HR doxylamine succinate 20 MG / pyridoxine hydrochloride 20 MG Extended Release Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1999651
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Doxylamine and Pyridoxine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 14 listed Doxylamine and Pyridoxine NDCs with Medicaid activity.
🔍 Compare Doxylamine and Pyridoxine products
A representative set of FDA-listed product records for Doxylamine and Pyridoxine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Delayed-release tablet | ||||
| DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 10; 10 mg/1; mg | Oral | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg | Oral | Analog Pharma | NDA AUTHORIZED GENERIC | View NDC → |
| 10; 10 mg/1; mg | Oral | Analog Pharma × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg | Oral | Bionpharma Inc., | ANDA | View NDC → |
| 10; 10 mg/1; mg | Oral | Bionpharma Inc., | ANDA | View NDC → |
| 10; 10 mg/1; mg | Oral | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg | Oral | Duchesnay USA, Inc. | NDA | View NDC → |
| 10; 10 mg/1; mg | Oral | Duchesnay USA, Inc. × 2 listings | NDA | View NDC → |
| 10; 10 mg/1; mg | Oral | Mylan Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 💊Extended-release tablet | ||||
| DOXYLAMINE SUCCINATE 20 mg/1; PYRIDOXINE HYDROCHLORIDE 20 mg | Oral | Duchesnay USA, Inc. | NDA | View NDC → |
| 20; 20 mg/1; mg | Oral | Duchesnay USA, Inc. × 2 listings | NDA | View NDC → |
Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Doxylamine and Pyridoxine NDCs →
📈 Doxylamine and Pyridoxine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Doxylamine and Pyridoxine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Doxylamine and Pyridoxine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Doxylamine and Pyridoxine FDA approval history
How Doxylamine and Pyridoxine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Doxylamine and Pyridoxine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Doxylamine and Pyridoxine supply and shortage status
Whether Doxylamine and Pyridoxine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Doxylamine and Pyridoxine brand names
🏭 Who makes Doxylamine and Pyridoxine: manufacturers and labelers
Doxylamine and Pyridoxine drug class (RxNorm)
Doxylamine and Pyridoxine belongs to the Antihistamine class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Doxylamine and Pyridoxine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Analog Pharma is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.