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 tablet has not been studied in women with hyperemesis gravidarum.  

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are white, round, biconvex, film-coated, delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. The tablets are imprinted on one side with “186” in black color.

Doxylamine succinate and pyridoxine hydrochloride 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 doxylamine succinate and pyridoxine hydrochloride [see Drug Interactions (7.1)]. 

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 with CNS depressants including alcohol [see Warnings and Precautions (5.1)]

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are white, round, biconvex, film-coated, delayed-release tablet imprinted on one side with “186” in black color.

Inactive ingredients are as follows: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer type C, microcrystalline cellulose, n-butanol, polyethylene glycol/macrogol, polysorbate 80, propylene glycol, shellac glaze, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate.

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 C17H22N2O • C4H6O4 and the molecular mass is 388.46. The structural formula is:

Doxylamine succinate is a white or almost 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 B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 • HCl and the molecular mass is 205.64. The structural formula is:

Pyridoxine hydrochloride is a white to practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and acetone, soluble in chloroform, insoluble in ether.

A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of doxylamine succinate and pyridoxine hydrochloride 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 or placebo. Two tablets of doxylamine succinate and 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 doxylamine succinate and pyridoxine hydrochloride-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 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 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)

*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.

16.1 How supplied

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white, round, biconvex, film-coated, delayed-release tablet contains 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and is imprinted on one side with “186” in black color. Doxylamine succinate and pyridoxine hydrochloride tablets are provided as follows:

NDC: 72162-1485-01: 100 Delayed Release Tablets in a BOTTLE.

16.2 Storage and Handling

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

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 until cleared to do so.

Inform women of the importance of not taking doxylamine succinate and pyridoxine hydrochloride 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 may result in false positive urine drug screening for methadone, opiates and PCP.

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets

(dok-sil′ă-mēn sŭk′si-nāt and peer-ih-DOX-een HIGH-droe-KLOR-ide)

What are doxylamine succinate and pyridoxine hydrochloride delayed-release tablets?

• Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are 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 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 should not take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets?

Do not take 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 taking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, tell your healthcare provider about all of your medical conditions, including if you:

• have asthma.
• 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 should 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 the following schedule for the usual way you should start taking 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, continueto 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets on an empty stomach with a glass of water.
• Take doxylamine succinate and pyridoxine hydrochloride delayed-release tablets whole. Do not crush, chew, or break doxylamine succinate and pyridoxine hydrochloride delayed-release tablets before swallowing. If you cannot swallow doxylamine succinate and pyridoxine hydrochloride delayed-release tablets whole, tell your healthcare provider.
• If you take too much doxylamine succinate and pyridoxine hydrochloride (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, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

What are the possible side effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets?

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may cause serious side effects, including drowsiness.

Drowsiness is a common side effect when taking doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, but can also be severe:

• Do not drive, operate heavy machinery, or 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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. Severe drowsiness can happen or become worse causing falls or accidents.

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets may cause false positive urine drug screening test for methadone, opiates and PCP.

These are not all the possible side effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets.

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 doxylamine succinate and pyridoxine hydrochloride delayed-release tablets?

• Store doxylamine succinate and pyridoxine hydrochloride delayed-release tablets between 68° to 77°F (20° to 25°C).
• Keep doxylamine succinate and pyridoxine hydrochloride delayed-release tablets dry, in a tightly closed container, and out of the light.
• Safely throw away medicine that is out of date or no longer needed.

Keep doxylamine succinate and pyridoxine hydrochloride delayed-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about doxylamine succinate and pyridoxine hydrochloride delayed-release tablets that is written for health professionals. Do not use doxylamine succinate and pyridoxine hydrochloride delayed-release tablets for a condition for which it was not prescribed. Do not give doxylamine succinate and pyridoxine hydrochloride delayed-release tablets to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in doxylamine succinate and pyridoxine hydrochloride delayed-release tablets?

Active ingredient: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).

Inactive ingredients: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer type C, microcrystalline cellulose, n-butanol, polyethylene glycol/macrogol, polysorbate 80, propylene glycol, shellac glaze, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical.

Dist. by:

Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:

Par Formulations Private Limited,

9/215, Pudupakkam, Kelambakkam - 603 103.

Made in India

Mfg. Lic. No.: TN00002122

OS186-01-74-01

Issued: 04/2019  

Doxylamine Succinate DR 10 mg Tablet, #100