DRUGS & SUPPLEMENTS
How is the drug helping you?
Doxylamine Succinate is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use
Doxylamine Succinate has not been studied in women with hyperemesis gravidarum.
Doxylamine Succinate is a fixed dose combination drug product of Doxylamine Succinate 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)
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 as described in the full prescribing information. (2)
Initially, take two Doxylamine Succinate 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 . Swallow tablets whole. Do not crush, chew, or split Doxylamine Succinate tablets.
Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for Doxylamine Succinate as her pregnancy progresses.
Doxylamine Succinate delayed-release tablets are white, round, film coated tablets containing 10 mg Doxylamine Succinate succinate and 10 mg pyridoxine hydrochloride. The tablets are imprinted with the pink image of a pregnant woman on one side.
Delayed-release tablets containing 10 mg Doxylamine Succinate succinate and 10 mg pyridoxine hydrochloride. (3)
Doxylamine Succinate is contraindicated in women with any of the following conditions:
Doxylamine Succinate may cause somnolence due to the anticholinergic properties of Doxylamine Succinate succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Doxylamine Succinate until cleared to do so by their healthcare provider.
Doxylamine Succinate 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 .
Doxylamine Succinate has anticholinergic properties and, therefore, should be used with caution in women with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.
The most common adverse reaction with Doxylamine Succinate (≥5 percent and exceeding the rate in placebo) is somnolence. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Duchesnay Inc. at 1-855-722-7734 or medicalinfoDoxylamine Succinateduchesnayusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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 . Adverse reactions for Doxylamine Succinate 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 (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence with Doxylamine Succinate than Placebo are Shown)
(N = 133)
(n = 128)
The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg Doxylamine Succinate 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
Use of Doxylamine Succinate 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 is not recommended.
A food-effect study demonstrated that the delay in the onset of action of Doxylamine Succinate may be further delayed, and a reduction in absorption may occur when tablets are taken with food . Therefore, Doxylamine Succinate should be taken on an empty stomach with a glass of water [ see Dosage and Administration (2)].
Pregnancy Category A. Doxylamine Succinate is intended for use in pregnant women.
Pregnancy Category A
Doxylamine Succinate is intended for use in pregnant women.
The combination of Doxylamine Succinate 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 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 succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.
The effects of Doxylamine Succinate succinate and pyridoxine hydrochloride on embryofetal development have been studied in rats and monkeys.
Once daily treatment of pregnant rats with Doxylamine Succinate succinate and pyridoxine hydrochloride during organogenesis (gestational day (GD) 6-15) resulted in increased fetal resorptions, decreased fetal body weight and increased skeletal variations with reduced ossification at doses 60 to 100 times the highest clinical dose based on body surface area.
Pregnant cynomolgus monkeys were treated once daily with Doxylamine Succinate succinate and pyridoxine hydrochloride during organogenesis (GD 22-50). At birth, there were no observed malformations, and no evidence of embryo, fetal or maternal toxicity at doses up to 3.2 times the highest proposed clinical dose based on body surface area. In a similarly designed study in pregnant cynomolgus and rhesus monkeys and baboons, ventricular septal defects (VSDs) were observed in the preterm (GD 100) fetuses. Doses used in this study were 0.5-20 times higher than the clinical dose based on body surface area, with no relationship between dose and incidence of VSD. There were no VSDs in infant monkeys at term. No VSDs were observed at GD 100 in cynomolgus monkeys administered the combination of Doxylamine Succinate succinate and pyridoxine hydrochloride for 4-day periods between 22 and 41 days of gestation.
Women should not breastfeed while using Doxylamine Succinate.
The molecular weight of Doxylamine Succinate 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 succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Doxylamine Succinate 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.
The safety and effectiveness of Doxylamine Succinate in children under 18 years of age have not been established.
Fatalities have been reported from Doxylamine Succinate 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 succinate. However, there is no correlation between the amount of Doxylamine Succinate ingested, the Doxylamine Succinate plasma level and clinical symptomatology.
Doxylamine Succinate 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 Succinate exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.
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).
Doxylamine Succinate (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of Doxylamine Succinate succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman.
Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
Doxylamine Succinate Succinate
Doxylamine Succinate succinate is classified as an antihistamine. The chemical name for Doxylamine Succinate 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 succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene.
Pyridoxine hydrochloride 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 or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.
The mechanism of action of Doxylamine Succinate is unknown.
The pharmacokinetics of Doxylamine Succinate has been characterized in healthy non-pregnant adult women. Pharmacokinetic results for Doxylamine Succinate and pyridoxine, including its vitamin B6 metabolites, pyridoxal, pyridoxal 5’-phosphate, pyridoxamine and pyridoxamine 5’-phosphate, are summarized in Tables 2 to 5.
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 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 3-18.
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 Succinate and pyridoxine are absorbed in the gastrointestinal tract, mainly in the jejunum.
The Cmax of Doxylamine Succinate and pyridoxine are achieved within 7.5 and 5.5 hours, respectively.
|1280.9 ± 369.3||83.3 ± 20.6||7.2 ± 1.9||3721.5 ± 1318.5||168.6 ± 38.5||7.8 ± 1.6|
|43.4 ± 16.5||32.6 ± 15.0||5.7 ± 1.5||64.5 ± 36.4||46.1 ± 28.3||5.6 ± 1.3|
|211.6 ± 46.1||74.3 ± 21.8||6.5 ± 1.4||1587.2 ± 550.0||210.0 ± 54.4||6.8 ± 1.2|
|1536.4 ± 721.5||30.0 ± 10.0||11.7 ± 5.3||6099.7 ± 1383.7||84.9 ± 16.9||6.3 ± 6.6|
|4.1 ± 2.7||0.5 ± 0.7||5.9 ± 2.1||2.6 ± 0.8||0.5 ± 0.2||6.6 ± 1.4|
|5.2 ± 3.8||0.7 ± 0.5||14.8 ± 6.6||94.5 ± 58.0||2.3 ± 1.7||12.4 ± 11.2|
Multiple-dose administration of Doxylamine Succinate results in increased concentrations of Doxylamine Succinate as well as increases in Doxylamine Succinate Cmax and AUC0-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 Succinate accumulates following multiple dosing.
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. The time to reach the maximum concentration is not affected by multiple doses.
|AUC0-last (ng-h/mL)||AUC0-inf (ng-h/mL)||Cmax (ng/mL)||Tmax (h)||T1/2el (h)|
| Doxylamine Succinate |
|911.4 ± 205.6||1280.9 ± 369.3||83.3 ± 20.6||7.2 ± 1.9||10.1 ± 2.1|
|3661.3 ± 1279.2||3721.5 ± 1318.5||168.6 ± 38.5||7.8 ± 1.6||11.9 ± 3.3|
| Pyridoxine |
|39.3 ± 16.5||43.4 ± 16.5||32.6 ± 15.0||5.7 ± 1.5||0.5 ± 0.2|
|59.3 ± 33.9||64.5 ± 36.4||46.1 ± 28.3||5.6 ± 1.3||0.5 ± 0.1|
The administration of food delays the absorption of both Doxylamine Succinate and pyridoxine. This delay is associated with a lower peak concentration of Doxylamine Succinate, but the extent of absorption is not affected.
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’-phosphate metabolites also contribute to the biological activity. Food significantly reduces the bioavailability of pyridoxine, lowering its Cmax and AUC by approximately 50% compared to fasting conditions. Similarly, food significantly reduces pyridoxal AUC and reduces its Cmax by 50% compared to fasting conditions. In contrast, food slightly increases pyridoxal 5’-phosphate Cmax and extent of absorption. As for pyridoxamine and pyridoxamine 5’-phosphate, the rate and extent of absorption seem to decrease under fed conditions.
|AUC0-t (ng-h/mL)||AUC0-inf (ng-h/mL)||Cmax (ng/mL)||Tmax (h)||T1/2el (h)|
| Doxylamine Succinate |
|Fasted||1407.2 ± 336.9||1447.9 ± 332.2||94.9 ± 18.4||5.1 ± 3.4||12.6 ± 3.4|
|Fed||1488.0 ± 463.2|| 1579.0 ± 422.7 ||75.7 ± 16.6||14.9 ± 7.4|| 12.5 ± 2.9 |
| Pyridoxine |
|Fasted||33.8 ± 13.7|| 39.5 ± 12.9 ||35.5 ± 21.4||2.5 ± 0.9|| 0.4 ± 0.2 |
|Fed||18.3 ± 14.5|| 24.2 ±14.0 ||13.7 ± 10.8||9.3 ± 4.0|| 0.5 ± 0.2 |
Pyridoxine is highly protein bound, primarily to albumin. Its main active metabolite, pyridoxal 5’-phosphate (PLP) accounts for at least 60% of circulating vitamin B6 concentrations.
Doxylamine Succinate is biotransformed in the liver by N-dealkylation to its principle metabolites N-desmethyl-doxylamine and N, N-didesmethyldoxylamine.
Pyridoxine is a prodrug primarily metabolized in the liver.
The principle metabolites of Doxylamine Succinate, N-desmethyl-doxylamine and N, N-didesmethyldoxylamine, are excreted by the kidney.
The terminal elimination half-life of Doxylamine Succinate and pyridoxine are 12.5 hours and 0.5 hours, respectively.
Table 5 – Terminal Elimination Half-Life (T1/2el) for Doxylamine Succinate Administered as a Single Dose of Two Tablets under Fasting Conditions in Healthy Non-Pregnant Adult Women
|Doxylamine||12.6 ± 3.4|
|Pyridoxine||0.4 ± 0.2|
|Pyridoxal||2.1 ± 2.2|
|Pyridoxal 5’-Phosphate||81.6 ± 42.2|
|Pyridoxamine||3.1 ± 2.5|
|Pyridoxamine 5’-Phosphate|| |
66.5 ± 51.3
Use in Specific Populations
Race: No pharmacokinetic studies have been conducted related to race.
Hepatic Impairment: No pharmacokinetic studies have been conducted in hepatic impaired patients.
Renal Impairment: No pharmacokinetic studies have been conducted in renal impaired patients.
Two-year carcinogenicity studies in rats and mice have been conducted with Doxylamine Succinate succinate. Doxylamine Succinate succinate is not likely to have human carcinogenic potential. The carcinogenic potential of pyridoxine hydrochloride has not been evaluated.
A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of Doxylamine Succinate 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 or placebo. Two tablets of Doxylamine Succinate 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 DICLEGIS-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 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 compared to placebo.
Table 6 – Change from Baseline in the Primary Endpoint, Pregnancy Unique-Quantification of Emesis (PUQE) Score at Day 15. (Intent-to-Treat Population with Last-Observation Carried Forward)
| PUQE Score ||Doxylamine Succinate Succinate + Pyridoxine Hydrochloride||Placebo||Treatment Difference [95% Confidence Interval]|
| Baseline |
Change from baseline at Day 15
| 9.0 ± 2.1 |
-4.8 ± 2.7
| 8.8 ± 2.1 |
-3.9 ± 2.6
|-0.7 [-1.2, -0.2]|
Doxylamine Succinate delayed-release tablets are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each white, round, film-coated, delayed-release tablet contains 10 mg Doxylamine Succinate succinate and 10 mg pyridoxine hydrochloride, and is imprinted on one side with the pink image of a pregnant woman. Doxylamine Succinate tablets are provided as follows:
NDC 55494-100-10 Bottles of 100.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.
See FDA-approved patient labeling
Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Doxylamine Succinate until cleared to do so.
Inform women of the importance of not taking Doxylamine Succinate 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.
Doxylamine Succinate® is a registered trademark of Duchesnay Inc.
U.S. Patent Nos. 6,340,695 & 7,560,122.
Duchesnay USA, Inc.
Bryn Mawr, PA, 19010
©2013, Duchesnay Inc. All rights reserved.
Doxylamine Succinate (dye-CLEE-gis)
(doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets
What is Doxylamine Succinate?
- Doxylamine Succinate is a prescription medicine used to treat nausea and vomiting of pregnancy in
women who have not improved with change in diet or other non-medicine treatments.
- It is not known if Doxylamine Succinate is safe and effective in children under 18 years of age.
Who should not take Doxylamine Succinate?
Do not take Doxylamine Succinate if you:
- are allergic to Doxylamine Succinate succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Doxylamine Succinate. See the end of this leaflet for a complete list of ingredients in Doxylamine Succinate.
- take monoamine oxidase inhibitors (MAOIs) (Marplan, Nardil, Emsam, Eldepryl, Zelapar, Parnate)
Before taking Doxylamine Succinate, tell your healthcare provider about all of your medical conditions, including;
- if you are breastfeeding or plan to breastfeed. Doxylamine Succinate can pass into your breast milk and may harm your baby. You should not breastfeed while using Doxylamine Succinate.
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?
- Talk to your healthcare provider about how much Doxylamine Succinate to take and when to take it.
- Take Doxylamine Succinate everyday as prescribed by your healthcare provider. Do not stop taking Doxylamine Succinate without talking to your healthcare provider first.
- See the following schedule for the usual way you should start taking Doxylamine Succinate:
- 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 Doxylamine Succinate on an empty stomach with a glass of water.
- Take Doxylamine Succinate tablets whole. Do not crush, chew, or break Doxylamine Succinate tablets before swallowing. If you cannot swallow Doxylamine Succinate tablets whole, tell your healthcare provider.
- If you take too much Doxylamine Succinate (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, 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?
Doxylamine Succinate may cause serious side effects, including drowsiness.
- 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. Severe drowsiness can happen or become worse causing falls or accidents.
These are not all the possible side effects of Doxylamine Succinate.
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?
- Store Doxylamine Succinate between 68°F to 77°F (20°C to 25°C).
- Keep Doxylamine Succinate 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 all medicines out of the reach of children.
General information about the safe and effective use of Doxylamine Succinate.
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 that is written for health professionals. Do not use Doxylamine Succinate for a condition for which it was not prescribed. Do not give Doxylamine Succinate to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Doxylamine Succinate?
Active ingredient: Doxylamine Succinate succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6)
Inactive ingredients: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue #2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
Distributed by: Duchesnay USA, Inc., Bryn Mawr, PA, 19010,
www.duchesnayusa.com or call 1-855-722-7734.
This Patient Information has been approved by the U.S. Food and Drug Administration
Bottle Label-Outside Front Cover with Imprint Area for Lot & Expiry
Bottle Label – Inside Cover
Depending on the reaction of the Doxylamine Succinate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Doxylamine Succinate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Doxylamine Succinate addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology