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Doxylamine succinate and pyridoxine hydrochloride 10 mg; 10 mg Tablet, Delayed Release, 100-count — NDC 0591-2132-01 (Billing 00591-2132-01)

by Actavis Pharma, Inc. · 100 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 100 tablets of Doxylamine succinate and pyridoxine hydrochloride 10 mg; 10 mg Tablet, Delayed Release from Actavis Pharma, Inc., marketed since Jun 2019 and currently FDA-listed; retail pharmacies pay about $1.09 per tablet (NADAC). It is this product's only package size.

NDC 00591-2132-01
🏷️ FDA NDC (as labeled) 0591-2132-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0591-2132-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0591 labeler · 2132 product · 01 package
Package marketed since
Jun 21, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0591213201 7
Medicaid fills, this package
632 prescriptions in the last four reported quarters
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 ↗
Past resolved recalls for this product (1)
Class II · Jan 18, 2022 · Terminated — Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient (Teva Pharmaceuticals USA) · FDA recall D-0461-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-2132-01
Product NDC 0591-2132
11-digit billing NDC 00591213201
NCPDP billing unit EA — each (per item)
RxCUI 1375948
UNII V9BI9B5YI2, 68Y4CF58BV
Application # ANDA205811
SPL Set ID 3670d66e-c1e4-42ce-8760-c3d5accad925
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-21
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 50309902100620
GPI class Doxylamine-Pyridoxine
GCN Seq No 004722
GCN 73860
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 DOXYLAMINE-PYRIDOXINE 10-10 MG
FDB brand name Doxylamine Succ-Pyridoxine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004722
  • GCN: 73860
  • GPI-14 (Medi-Span): 50309902100620
  • HICL (First Databank): 001970
  • AHFS class code: 48:04.04.00
  • RxCUI (RxNorm): 1375948
Why two NDCs? The FDA registers this code as 0591-2132-01 — a 4-4-2 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 labeler segment → 00591-2132-01. 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 DOXYLAMINE-PYRIDOXINE 10-10 MG 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 eaPer package
Retail pharmacies payNADAC · weekly $1.092 $109.16 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $1.36 $135.92 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $3.54 $353.50 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $3.578 $1.092
▼ Down 67% over the last 24 months.
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 Marketing startMarketing endStatus
00591-2132-01 You're viewing this Main listing 100 TABLET, DELAYED RELEASE in 1 BOTTLE 2019-06-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mgthis 00591-2132-01 Actavis 100 tablets $1.092 AB Availability likely —
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 49884-0186-01 Par 100 tablets $1.092 AB Availability likely —
Doxylamine succinate and Pyridoxine hydrochloride 10 mg/1; 10 mg 69452-0206-20 Bionpharma 100 tablets $1.092 AB Availability likely —
Doxylamine succinate and pyridoxine hydrochloride 10 mg/1; 10 mg 70505-0100-10 Analog 100 tablets $1.092 AB Availability likely —
Diclegis 10 mg/1; 10 mg 55494-0100-10 Duchesnay 100 tablets $1.676 AB Availability likely +54%
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 63629-2184-01 Bryant 100 tablets — AB FDA listed —
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/1; 10 mg 72162-1485-01 Bryant 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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 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 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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 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.

13 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

LabelerActavis Pharma, Inc.
Application holderACTAVIS LABORATORIES FL INC
FDA applicationANDA205811 (ANDA)
Labeler code00591
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 98 words ▾

1 INDICATIONS AND USAGE Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Take two tablets daily at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) as described in the full prescribing information. ( 2 )

2.1Dosage Information Initially, take two doxylamine succinate and pyridoxine hydrochloride delayed-release tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime).

If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime). The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily.

Take on an empty stomach with a glass of water [see Clinical Pharmacology (12.3) ] . Swallow tablets whole. Do not crush, chew, or split doxylamine succinate and pyridoxine hydrochloride delayed-release tablets.

Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for doxylamine succinate and pyridoxine hydrochloride delayed-release tablets as her pregnancy progresses.

💊 Dosage Forms and Strengths 72 words ▾

3 DOSAGE FORMS AND STRENGTHS Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are white to off white, round, biconvex film coated tablets, plain on both sides containing 10 mg doxylamine succinate, USP and 10 mg pyridoxine hydrochloride, USP. The tablets are printed with “ 2132 ” on one side with black ink and plain on the other. Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. ( 3 )

⛔ Contraindications 94 words ▾

4 CONTRAINDICATIONS Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets [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 Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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: doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may interfere with urine screening for methadone, opiates and PCP ( 5.3 )

5.1Activities Requiring Mental Alertness Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets until cleared to do so by their healthcare provider. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have anticholinergic properties and, therefore, should be used with caution in women with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets with CNS depressants including alcohol [see Warnings and Precautions (5.1) ] The most common adverse reaction with doxylamine succinate and pyridoxine hydrochloride delayed-release tablets (≥5 percent and exceeding the rate in placebo) is somnolence.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets were compared to placebo 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 for doxylamine succinate and pyridoxine hydrochloride delayed-release tablets that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1. Table 1: Number (Percent) of Subjects with ≥ 5 Percent Adverse Reactions in a 15-Day Placebo-Controlled Study of Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence with Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets than Placebo are Shown) Doxylamine Succinate and Pyridoxine Hydrochloride) Delayed-release 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 maculo-papular

🔄 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is not recommended.

7.2Drug-Food Interactions A food-effect study demonstrated that the delay in the onset of action of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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, doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is not recommended.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for use in pregnant women. ( 8.1 )

8.1Pregnancy Risk Summary Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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% to 4% and 15% to 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 doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.

8.2Lactation Women should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 186 words ▾

8.1Pregnancy Risk Summary Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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% to 4% and 15% to 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 doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.

🧒 Pediatric Use 105 words ▾

8.4Pediatric Use The safety and effectiveness of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 100 words ▾

10 OVERDOSAGE

10.1Signs and Symptoms of Overdose Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is a delayed-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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is unknown.

12.3Pharmacokinetics The pharmacokinetics of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets has been characterized in healthy non-pregnant adult women. Pharmacokinetic results for doxylamine and pyridoxine, including its vitamin B6 metabolites, pyridoxal, pyridoxal 5’-phosphate, pyridoxamine and pyridoxamine 5’-phosphate, are summarized in Tables 2 to 5. Absorption A single-dose (two tablets) and multiple-dose (four tablets daily), open-label study was conducted to assess the safety and pharmacokinetic profile of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets administered in healthy non-pregnant adult women.

Single-doses (two tablets at bedtime) were administered on Days 1 and 2. Multiple-doses (one tablet in the morning, one tablet in the afternoon and two tablets at bedtime) were administered on Days 3 to 18. Blood samples for pharmacokinetic analysis were collected pre-and post-dose on Days 2 and 18 as well as pre-dose prior to bedtime dose only (trough) on Days 9, 10, 11, 16, 17, and 18.

Doxylamine and pyridoxine are absorbed in the gastrointestinal tract, mainly in the jejunum. The C max of doxylamine and pyridoxine are achieved within 7.5 and 5.5 hours, respectively (see Table 2). Table 2 – Single-Dose and Multiple-Dose Pharmacokinetics of Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets in Healthy Non-Pregnant Adult Women Sin g le Dose Multiple D o se A U C 0-inf ( n g • h/mL) C m ax (ng/m L ) T max (h) A U C 0-inf ( n g • h/mL) C m ax (ng/m L ) T max (h) Dox y l a mine 1280.9 ± 369.3 83.3 ± 20.6 7.2 ± 1.9 3721.5 ± 1318.5 168.6 ± 38.5 7.8 ±

1.6Pyri d ox i ne 43.4 ± 16.5 32.6 ± 15.0 5.7 ± 1.5 64.5 ± 36.4 46.1 ± 28.3 5.6 ±

1.3Pyri d o xal 211.6 ± 46.1 74.3 ± 21.8 6.5 ± 1.4 1587.2 ± 550.0 210.0 ± 54.4 6.8 ±

1.2Pyri d o xal 5` P ho s p h ate 1536.4 ± 721.5 30.0 ± 10.0 11.7 ± 5.3 6099.7 ± 1383.7 84.9 ± 16.9 6.3 ±

6.6Pyridoxamine 4.1 ± 2.7 0.5 ± 0.7 5.9 ± 2.1 2.6 ± 0.8 0.5 ± 0.2 6.6 ±

1.4Pyridoxamine 5 '-p h o s p h ate 5.2 ± 3.8 0.7 ± 0.5 14.8 ± 6.6 94.5 ± 58.0 2.3 ± 1.7 12.4 ±

11.2Multiple-dose administration of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets results in increased concentrations of doxylamine as well as increases in doxylamine C max and AUC 0-last of absorption. The time to reach the maximum concentration is not affected by multiple doses. The mean accumulation index is more than 1.0 suggesting that doxylamine accumulates following multiple dosing (see Table 3).

Although no accumulation was observed for pyridoxine, the mean accumulation index for each metabolite (pyridoxal, pyridoxal 5’-phosphate, and pyridoxamine 5’-phosphate) is more than 1.0 following multiple-dose administration of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. The time to reach the maximum concentration is not affected by multiple doses (see Table 2). Table 3 – Pharmacokinetics of Doxylamine and Pyridoxine Following Single Dose and Multiple Dose Administration of Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets to Healthy Non-Pregnant Adult Women AU C 0-last (ng • h/mL) A U C 0-inf (ng • h/mL) C m ax (ng/m L ) T max (h) T 1/2el (h) Dox y l a mine Mean±SD N=18 Single 911.4 ± 205.6 1280.9 ± 369.3 83.3 ± 20.6 7.2 ± 1.9 10.1 ±

2.1Multiple 3661.3 ± 1279.2 3721.5 ± 1318.5 168.6 ± 38.5 7.8 ± 1.6 11.9 ±

3.3Pyri d ox i ne Mean±SD N=18 Single 39.3 ± 16.5 43.4 ± 16.5 32.6 ± 15.0 5.7 ± 1.5 0.5 ±

0.2Multiple 59.3 ± 33.9 64.5 ± 36.4 46.1 ± 28.3 5.6 ± 1.3 0.5 ±

0.1Food Effect The administration of food delays the absorption of both doxylamine and pyridoxine. This delay is associated with a lower peak concentration of doxylamine, but the extent of absorption is not affected (see Table 4). The effect of food on the peak concent… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 18 words ▾

12.1Mechanism of Action The mechanism of action of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is unknown.

📦 How Supplied / Storage and Handling 211 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How supplied Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 100 bottle count is supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white to off white, round, biconvex film-coated, delayed-release tablet contains 10 mg doxylamine succinate, USP and 10 mg pyridoxine hydrochloride, USP and is printed with “ 2132 ” on one side with black ink and plain on the other. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are provided as follows: NDC 0591-2132-01 Bottles of 100.

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

16.1How supplied Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 100 bottle count is supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white to off white, round, biconvex film-coated, delayed-release tablet contains 10 mg doxylamine succinate, USP and 10 mg pyridoxine hydrochloride, USP and is printed with “ 2132 ” on one side with black ink and plain on the other. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are provided as follows: NDC 0591-2132-01 Bottles of 100.

📦 Storage and Handling 32 words ▾

16.2Storage and Handling Store at 20° to 25°C (68° to 77°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 Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white to off white, biconvex film-coated, delayed-release tablets containing 10 mg of doxylamine succinate, USP and 10 mg of pyridoxine hydrochloride, USP. Tablets are printed with “ 2132 ” on one side with black ink and plain on the other. Inactive ingredients are as follows: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, magnesium stearate, magnesium trisilicate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, polysorbate 80, propylene glycol, talc, titanium dioxide.

Doxylamine Succinate Doxylamine succinate, USP is classified as an antihistamine. The chemical name for doxylamine succinate, USP is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The molecular 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, USP 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, USP is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride, USP is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride.

The molecular formula is C 8 H 11 NO 3 • HCl and the molecular mass is 205.64. The structural formula is: Pyridoxine hydrochloride, USP is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether. structural formula structural formula

💬 Information for Patients 130 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Somnolence and Severe Drowsiness Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets until cleared to do so. Inform women of the importance of not taking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may result in false positive urine drug screening for methadone, opiates and PCP. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 9/2025

🍼 Nursing Mothers 107 words ▾

8.2Lactation Women should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets has been characterized in healthy non-pregnant adult women. Pharmacokinetic results for doxylamine and pyridoxine, including its vitamin B6 metabolites, pyridoxal, pyridoxal 5’-phosphate, pyridoxamine and pyridoxamine 5’-phosphate, are summarized in Tables 2 to 5. Absorption A single-dose (two tablets) and multiple-dose (four tablets daily), open-label study was conducted to assess the safety and pharmacokinetic profile of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets administered in healthy non-pregnant adult women.

Single-doses (two tablets at bedtime) were administered on Days 1 and 2. Multiple-doses (one tablet in the morning, one tablet in the afternoon and two tablets at bedtime) were administered on Days 3 to 18. Blood samples for pharmacokinetic analysis were collected pre-and post-dose on Days 2 and 18 as well as pre-dose prior to bedtime dose only (trough) on Days 9, 10, 11, 16, 17, and 18.

Doxylamine and pyridoxine are absorbed in the gastrointestinal tract, mainly in the jejunum. The C max of doxylamine and pyridoxine are achieved within 7.5 and 5.5 hours, respectively (see Table 2). Table 2 – Single-Dose and Multiple-Dose Pharmacokinetics of Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets in Healthy Non-Pregnant Adult Women Sin g le Dose Multiple D o se A U C 0-inf ( n g • h/mL) C m ax (ng/m L ) T max (h) A U C 0-inf ( n g • h/mL) C m ax (ng/m L ) T max (h) Dox y l a mine 1280.9 ± 369.3 83.3 ± 20.6 7.2 ± 1.9 3721.5 ± 1318.5 168.6 ± 38.5 7.8 ±

1.6Pyri d ox i ne 43.4 ± 16.5 32.6 ± 15.0 5.7 ± 1.5 64.5 ± 36.4 46.1 ± 28.3 5.6 ±

1.3Pyri d o xal 211.6 ± 46.1 74.3 ± 21.8 6.5 ± 1.4 1587.2 ± 550.0 210.0 ± 54.4 6.8 ±

1.2Pyri d o xal 5` P ho s p h ate 1536.4 ± 721.5 30.0 ± 10.0 11.7 ± 5.3 6099.7 ± 1383.7 84.9 ± 16.9 6.3 ±

6.6Pyridoxamine 4.1 ± 2.7 0.5 ± 0.7 5.9 ± 2.1 2.6 ± 0.8 0.5 ± 0.2 6.6 ±

1.4Pyridoxamine 5 '-p h o s p h ate 5.2 ± 3.8 0.7 ± 0.5 14.8 ± 6.6 94.5 ± 58.0 2.3 ± 1.7 12.4 ±

11.2Multiple-dose administration of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets results in increased concentrations of doxylamine as well as increases in doxylamine C max and AUC 0-last of absorption. The time to reach the maximum concentration is not affected by multiple doses. The mean accumulation index is more than 1.0 suggesting that doxylamine accumulates following multiple dosing (see Table 3).

Although no accumulation was observed for pyridoxine, the mean accumulation index for each metabolite (pyridoxal, pyridoxal 5’-phosphate, and pyridoxamine 5’-phosphate) is more than 1.0 following multiple-dose administration of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. The time to reach the maximum concentration is not affected by multiple doses (see Table 2). Table 3 – Pharmacokinetics of Doxylamine and Pyridoxine Following Single Dose and Multiple Dose Administration of Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets to Healthy Non-Pregnant Adult Women AU C 0-last (ng • h/mL) A U C 0-inf (ng • h/mL) C m ax (ng/m L ) T max (h) T 1/2el (h) Dox y l a mine Mean±SD N=18 Single 911.4 ± 205.6 1280.9 ± 369.3 83.3 ± 20.6 7.2 ± 1.9 10.1 ±

2.1Multiple 3661.3 ± 1279.2 3721.5 ± 1318.5 168.6 ± 38.5 7.8 ± 1.6 11.9 ±

3.3Pyri d ox i ne Mean±SD N=18 Single 39.3 ± 16.5 43.4 ± 16.5 32.6 ± 15.0 5.7 ± 1.5 0.5 ±

0.2Multiple 59.3 ± 33.9 64.5 ± 36.4 46.1 ± 28.3 5.6 ± 1.3 0.5 ±

0.1Food Effect The administration of food delays the absorption of both doxylamine and pyridoxine. This delay is associated with a lower peak concentration of doxylamine, but the extent of absorption is not affected (see Table 4). The effect of food on the peak concentration and the extent of absorption of the pyridoxine component is more complex because the pyridoxal, pyridoxamine, pyridoxal 5’-phosphate and pyridoxamine 5’-pho… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets or placebo. Two tablets of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets-treated patients 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 doxylamine succinate and pyridoxine hydrochloride delayed-release 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 doxylamine succinate and pyridoxine hydrochloride delayed-release 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 Scor e * Doxylamine Succinate + Pyri d ox i ne H y d r och l oride Placebo Treatm e nt Difference [9 5 % Confid e nce Interval] B a seline C h a n ge f r om baseline at Da y 15 9.0 ± 2.1 -4.8 ± 2.7 8.8 ± 2.1 -3.9 ± 2.6 -0.7 [-1.2, -0.2] *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.

🧪 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.

📄 Patient Package Insert ~3 min read ▾

Patient Information Doxylamine Succinate (dox il′ a meen sux′ i nate) and Pyridoxine Hydrochloride (pir′′ i dox′ een hye′′ droe klor′ ide) Delayed-release Tablets What are doxylamine succinate and pyridoxine hydrochloride delayed-release tablets ? Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are safe and effective in children under 18 years of age. Who s h ou l d not ta k e doxylamine succinate and pyridoxine hydrochloride delayed-release tablets ?

Do not t a k e doxylamine succinate and pyridoxine hydrochloride delayed-release tablets if you: are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. See the end of this leaflet for a complete list of ingredients in doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. 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 t aking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets , tell your h eal th care prov i der about all of yo u r medi c a l co nditions, 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. Doxylamine succinate and pyridoxine hydrochloride can pass into your breast milk and may harm your baby.

You should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. How s h ou l d I take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets ?

Talk to your healthcare provider about how much doxylamine succinate and pyridoxine hydrochloride delayed-release tablets to take and when to take it. Take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets everyday as prescribed by your healthcare provider. Do not stop taking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets without talking to your healthcare provider first.

See t he fo l low i ng s c h edule for t he us u a l way you s h ould s t art t a ki n g doxylamine succinate and pyridoxine hydrochloride delayed-release tablets : ● Day 1- Take 2 tablets, by mouth at bedtime. ● Day 2- Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise. ● Day 3- If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime). ● Day 4- If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime).

If you still had nausea and vomiting on Day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime). Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day. Take d… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 42 words ▾

Principal Display Panel NDC 0591-2132-01 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg PHARMACIST: Dispense with the accompany Patient Information to each patient. WARNING: Swallow tablets whole. Do not crush, chew, or split the tablets. 100 Tablets Rx only 1

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
632
Units reimbursed last 4 qtrs
48.9K
Gross reimbursed last 4 qtrs
$66.5K
Avg / prescription
$105.25
Avg / unit
$1.3592
Latest quarter Q1 2026
152Rx
Medicaid pays / ea
$1.3592
gross reimbursed
vs
NADAC / ea
$1.0916
acquisition cost
=
Spread
+$0.2676
+25% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 632 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 48,937 units · 250 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
250250
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 250 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 00591-2131-55 · Actavis 00591-2159-90 · Actavis →
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.