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TL;DR â Quick Summary
Key facts from the full medication guide below
đŠēWhat it's for
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.
đHow to take it
The dose of doxepin tablets should be individualized. Initial dose: 6 mg, once daily for adults ( 2.1) and 3 mg, once daily for the elderly. ( 2.1, 2.2) Take within 30 minutes of bedtime. Total daily dose should not exceed 6 mg. ( 2.3) Should not be taken within 3 hours of a meal.
âšī¸Common side effects
The following serious adverse reactions are discussed in greater detail in other sections of labeling: Abnormal thinking and behavioral changes [ see Warnings and Precautions ( 5.2) ]. Suicide risk and worsening of depression [ see Warnings and Precautions ( 5.3) ]. CNS Depressant effects [ see Warnings and Precautions ( 5.4) ].
â ī¸Serious risks
Need to Evaluate for comorbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.1) Abnormal thinking, behavioral changes, complex behaviors: May include Sleep-driving and hallucinations. Immediately evaluate any new onset behavioral changes. ( 5.2) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose. ( 5.3) CNS-depressant effects: Use can impair alertness and motor coordination.
đInteractions & cautions
MAO inhibitors: Doxepin tablets should not be administered in patients on MAOIs within the past two weeks. ( 4.2) Cimetidine: Increases exposure to doxepin. ( 7.2) Alcohol: Sedative effects may be increased with doxepin. ( 7.3, 5.4) CNS Depressants and Sedating Antihistamines: Sedative effects may be increased with doxepin. ( 7.4, 5.4) Tolazamide: A case of severe hypoglycemia has been reported.
đĻStorage & missed dose
Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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The dose of doxepin tablets should be individualized. Initial dose: 6 mg, once daily for adults ( 2.1) and 3 mg, once daily for the elderly. ( 2.1, 2.2) Take within 30 minutes of bedtime. Total daily dose should not exceed 6 mg. ( 2.3) Should not be taken within 3 hours of a meal. ( 2.3, 12.3)
Doxepin Tablets are available containing 3.39 mg or 6.78 mg of doxepin hydrochloride, USP equivalent to 3 mg or 6 mg of doxepin, respectively. The 3 mg tablets are light blue, round, biconvex, beveled edge tablet debossed with 161 on one side of the tablet and plain on the other side. They are available as follows: NDC 72819-161-03 bottles of 30 tablets NDC 72819-161-10 bottles of 100 tablets NDC 72819-161-11 bottles of 500 tablets The 6 mg tablets are blue, round, biconvex, beveled edge tablet debossed with 162 on one side of the tablet and plain on the other side. They are available as follows NDC 72819-162-03 bottles of 30 tablets NDC 72819-162-10 bottles of 100 tablets NDC 72819-162-11 bottles of 500 tablets
Doxepin Tablets are available containing 3.39 mg or 6.78 mg of doxepin hydrochloride, USP equivalent to 3 mg or 6 mg of doxepin, respectively. Doxepin tablets are not scored. The 3 mg tablets are light blue, round, biconvex, beveled edge tablet debossed with 161on one side of the tablet and plainon the other side. The 6 mg tablets are blue, round, biconvex, beveled edge tablet debossed with 162on one side of the tablet and plainon the other side. 3 mg and 6 mg tablets. Tablets not scored. ( 3)
Hypersensitivity to doxepin hydrochloride, inactive ingredients, or other dibenzoxepines. ( 4.1) Co-administration with Monoamine Oxidase Inhibitors (MAOIs): Do not administer if patient is taking MAOIs or has used MAOIs within the past two weeks. ( 4.2) Untreated narrow angle glaucoma or severe urinary retention. ( 4.3)
Need to Evaluate for comorbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.1) Abnormal thinking, behavioral changes, complex behaviors: May include Sleep-driving and hallucinations. Immediately evaluate any new onset behavioral changes. ( 5.2) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose. ( 5.3) CNS-depressant effects: Use can impair alertness and motor coordination. Avoid engaging in hazardous activities such as operating a motor vehicle or heavy machinery after taking drug. ( 5.4) Do not use with alcohol. ( 5.4, 7.3) Potential additive effects when used in combination with CNS depressants or sedating antihistamines. Dose reduction may be needed. ( 5.4, 7.4) Patients with severe sleep apnea: Doxepin tablets are ordinarily not recommended for use in this population. ( 8.7)
The following serious adverse reactions are discussed in greater detail in other sections of labeling: Abnormal thinking and behavioral changes [ see Warnings and Precautions ( 5.2) ]. Suicide risk and worsening of depression [ see Warnings and Precautions ( 5.3) ]. CNS Depressant effects [ see Warnings and Precautions ( 5.4) ]. The most common treatment-emergent adverse reactions, reported in 2% of patients treated with doxepin tablets, and more commonly than in patients treated with placebo, were somnolence/sedation, nausea, and upper respiratory tract infection. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact RK Pharma, at 1-844-757-4276 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
MAO inhibitors: Doxepin tablets should not be administered in patients on MAOIs within the past two weeks. ( 4.2) Cimetidine: Increases exposure to doxepin. ( 7.2) Alcohol: Sedative effects may be increased with doxepin. ( 7.3, 5.4) CNS Depressants and Sedating Antihistamines: Sedative effects may be increased with doxepin. ( 7.4, 5.4) Tolazamide: A case of severe hypoglycemia has been reported. ( 7.5)
Pregnancy: Third trimester use may increase the risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. ( 8.1) Lactation: Breastfeeding not recommended. ( 8.2) Pediatric Use: Safety and effectiveness have not been evaluated. ( 8.4) Geriatric Use: The recommended starting dose is 3 mg. Monitor prior to considering dose escalation. ( 2.2, 8.5) Use in Patients with Comorbid Illness: Initiate treatment with 3 mg in patients with hepatic impairment or tendency to urinary retention. ( 8.6, 4.3)
Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see Data). There are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (TCAs), including doxepin, during pregnancy (see Clinical Considerations).In animal reproduction studies, oral administration of doxepin to rats and rabbits during the period of organogenesis caused adverse developmental effects at doses 65 and 23 times the maximum recommended human dose (MRHD) of 6 mg/day based on AUC, respectively. Oral administration of doxepin to pregnant rats during pregnancy and lactation resulted in decreased pup survival and a delay in pup growth at doses 60 times the MRHD based on AUC (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: Neonates exposed to TCAs, including doxepin, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome. Monitor neonates who were exposed to doxepin in the third trimester of pregnancy for poor neonatal adaptation syndrome . Data Human Data Published epidemiologic studies of pregnant women exposed to TCAs, including doxepin, have not established an association with major birth defects, miscarriage or adverse maternal outcomes. Methodological limitations of these observational studies include small sample size and lack of adequate controls. Animal Data When doxepin (30, 100, and 150 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, developmental toxicity (increased incidences of fetal structural abnormalities consisting of non-ossified bones in the skull and sternum and decreased fetal body weights) and maternal toxicity were noted at 100 mg/kg/day, which produced plasma exposures (AUCs) of doxepin and nordoxepin (the primary metabolite in humans) approximately 65 and 53 times, respectively, the plasma AUCs at the MRHD. The plasma exposures at the no-effect dose for embryo-fetal developmental toxicity in rats (30 mg/kg/day) are approximately 6 and 5 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD. When doxepin (10, 30, and 60 mg/kg/day) was administered orally to pregnant rabbits during the period of organogenesis, fetal body weights were reduced at the highest dose in the absence of maternal toxicity, which produced plasma AUCs of doxepin and nordoxepin approximately 23 and 56 times, respectively, the plasma AUCs at the MRHD. The plasma exposures at the no-effect dose for developmental effects (30 mg/kg/day) are approximately 8 and 25 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD. Oral administration of doxepin (10, 30, and 100 mg/kg/day) to rats throughout pregnancy and lactation resulted in decreased pup survival and transient growth delay at the highest dose, which produced plasma AUCs of doxepin and nordoxepin approximately 60 and 39 times, respectively, the plasma AUCs at the MRHD. The plasma exposures at the no-effect dose for adverse effects on pre- and postnatal development in rats (30 mg/kg/day) are approximately 2 and 1 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD.
Risk Summary Data from the published literature report the presence of doxepin and nordoxepin in human milk. There are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to doxepin. There are no data on the effects of doxepin on milk production. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, clinicians should advise patients that breastfeeding is not recommended during treatment with doxepin tablets. Clinical Considerations Infants exposed to doxepin through breast milk should be monitored for excess sedation, respiratory depression and hypotonia.
Infertility Based on results from animal fertility studies conducted in rats, doxepin may reduce fertility in females and males of reproductive potential [see Nonclinical Toxicology ( 13.1)] . It is unknown if the effects are reversible.
The safety and effectiveness of doxepin tablets in pediatric patients have not been evaluated.
A total of 362 subjects who were 65 years and 86 subjects who were 75 years received doxepin tablets in controlled clinical studies. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Greater sensitivity of some older individuals cannot be ruled out. Sleep-promoting drugs may cause confusion and over-sedation in the elderly. A starting dose of 3 mg is recommended in this population and evaluation prior to considering dose escalation is recommended [ see Dosage and Administration ( 2.2) ].
Doxepin is not a controlled substance.
Doxepin is not associated with abuse potential in animals or in humans. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of doxepin (e.g., incrementation of dose, drug-seeking behavior).
In a brief assessment of adverse events observed during discontinuation of doxepin following chronic administration, no symptoms indicative of a withdrawal syndrome were observed. Thus, doxepin does not appear to produce physical dependence.
Doxepin is routinely administered for indications other than insomnia at doses 10- to 50-fold higher than the highest recommended dose of doxepin tablets. The signs and symptoms associated with doxepin use at doses several-fold higher than the maximum recommended dose (Excessive dose) of doxepin tablets for the treatment of insomnia are described [ see Overdosage ( 10.1) ], as are signs and symptoms associated with higher multiples of the maximum recommended dose (Critical overdose) [ see Overdosage ( 10.2) ].
Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1-propanamine, 3-dibenz[ b,e]oxepin-11(6 H)ylidene- N, N-dimethyl-hydrochloride. It has the following structure: Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C 19H 21NO HCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose.
The mechanism of action of doxepin in sleep maintenance is unclear; however, doxepin s effect could be mediated through antagonism of the H1 receptor .
Doxepin has high binding affinity to the H 1receptor (Ki < 1 nM). Cardiac Electrophysiology In a thorough QTc prolongation clinical study in healthy subjects, doxepin had no effect on QT intervals or other electrocardiographic parameters after multiple daily doses up to 50 mg.
Absorption The median time to peak concentrations (T max) of doxepin occurred at 3.5 hours postdose after oral administration of a 6 mg dose to fasted healthy subjects. Peak plasma concentrations (C max) of doxepin increased in approximately a dose-proportional manner for 3 mg and 6 mg doses. The AUC was increased by 41% and C maxby 15% when 6 mg doxepin tablets were administered with a high fat meal. Additionally, compared to the fasted state, T maxwas delayed by approximately 3 hours. Therefore, for faster onset and to minimize the potential for next day effects, it is recommended that doxepin tablets not be taken within 3 hours of a meal [ see Dosage and Administration ( 2.3) ]. Distribution Doxepin is widely distributed throughout the body tissues. The mean apparent volume of distribution following a single 6 mg oral dose of doxepin tablets to healthy subjects was 11,930 liters. Doxepin is approximately 80% bound to plasma proteins. Metabolism Following oral administration, doxepin is extensively metabolized by oxidation and demethylation. The primary metabolite is N-desmethyldoxepin (nordoxepin). The primary metabolite undergoes further biotransformation to glucuronide conjugates. In vitrostudies have shown that CYP2C19 and CYP2D6 are the major enzymes involved in doxepin metabolism, and that CYP1A2 and CYP2C9 are involved to a lesser extent. Doxepin appears not to have inhibitory effects on human CYP enzymes at therapeutic concentrations. The potential of doxepin to induce metabolizing enzymes is not known. Doxepin is not a Pgp substrate. Excretion Doxepin is excreted in the urine mainly in the form of glucuronide conjugates. Less than 3% of a doxepin dose is excreted in the urine as parent compound or nordoxepin. The apparent terminal half-life (t ) of doxepin was 15.3 hours and for nordoxepin was 31 hours. Drug Interactions Since doxepin is metabolized by CYP2C19 and CYP2D6, inhibitors of these CYP isozymes may increase the exposure of doxepin. Cimetidine The effect of cimetidine, a non-specific inhibitor of CYP1A2, 2C19, 2D6, and 3A4, on doxepin plasma concentrations was evaluated in healthy subjects. When cimetidine 300 mg BID was co-administered with a single dose of doxepin tablets 6 mg, there was approximately a 2-fold increase in doxepin C maxand AUC compared to doxepin given alone. A maximum dose of doxepin in adults and elderly should be 3 mg, when doxepin is co-administered with cimetidine. Sertraline The effect of sertraline HCl, a selective serotonin reuptake inhibitor, on doxepin plasma concentrations was evaluated in a daytime study conducted with 24 healthy subjects. Following co-administration of doxepin 6 mg with sertraline 50 mg (at steady-state), the doxepin mean AUC and C maxestimates were approximately 21% and 32% higher, respectively, than those obtained following administration of doxepin alone. Psychomotor function as measured by the digit symbol substitution test and symbol copy test performance was decreased more at 2 to 4 hours post dosing for the combination of sertraline and doxepin as compared to doxepin alone, but subjective measures of alertness were comparable for the two treatments. Special Populations Renal Impairment The effects of renal impairment on doxepin pharmacokinetics have not been studied. Because only small amounts of doxepin and nordoxepin are eliminated in the urine, renal impairment would not be expected to result in significantly altered doxepin concentrations. Hepatic Impairment The effects of doxepin in patients with hepatic impairment have not been studied. Because doxepin is extensively metabolized by hepatic enzymes, patients with hepatic impairment may display higher doxepin concentrations than healthy individuals. Poor Metabolizers of CYPs Poor metabolizers of CYP2C19 and CYP2D6 may have higher doxepin plasma levels than normal subjects.
Carcinogenesis No evidence of carcinogenic potential was observed when doxepin was administered orally to hemizygous Tg.rasH2 mice for 26 weeks at doses of 25, 50, 75, and 100 mg/kg/day. Mutagenesis Doxepin was negative in in vitro(bacterial reverse mutation, chromosomal aberration in human lymphocytes) and in vivo(rat micronucleus) assays. Impairment of Fertility When doxepin (10, 30, and 100 mg/kg/day) was orally administered to male and female rats prior to, during and after mating, adverse effects on fertility (increased copulatory interval and decreased corpora lutea, implantation, viable embryos and litter size) and sperm parameters (increased percentages of abnormal sperm and decreased sperm motility) were observed. The plasma exposures (AUC) for doxepin and nordoxepin at the no-effect dose for adverse effects on reproductive performance and fertility in rats (10 mg/kg/day) are less than those in humans at the maximum recommended human dose of 6 mg/day.
Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Sleep-driving and Other Complex Behaviors There have been reports of people getting out of bed after taking a hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since sleep-driving can be dangerous. This behavior is more likely to occur when a hypnotic is taken with alcohol or other central nervous system depressants [ see Warnings and Precautions ( 5.2, 5.4) and Drug Interactions ( 7.3, 7.4) ]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a hypnotic. As with sleep-driving , patients usually do not remember these events. In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as sleep-driving and other complex behaviors immediately to the prescriber. Suicide Risk and Worsening of Depression Patients, their families, and their caregivers should be encouraged to be alert to worsening of depression, including suicidal thoughts and actions. Such symptoms should be reported to the patient's prescriber or health professional. Administration Instructions Patients should be counseled to take doxepin tablets within 30 minutes of bedtime and should confine their activities to those necessary to prepare for bed. Doxepin tablets should not be taken with or immediately after a meal [ see Dosage and Administration ( 2.3) ]. Advise patients NOT to take doxepin tablets when drinking alcohol [ see Warnings and Precautions ( 5.2, 5.4) and Drug Interactions ( 7.3) ]. Pregnancy Advise patients that doxepin tablets use late in pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support or tube feeding [see Use in Specific Populations ( 8.1)]. Lactation Advise patients that breastfeeding is not recommended during treatment with doxepin tablets [see Use in Specific Populations ( 8.2)]. Infertility Inform patients that doxepin tablets may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations ( 8.3) and Nonclinical Toxicology ( 13.1)].
D oxepin Tablets (dox' e pin) What is the most important information I should know about doxepin tablets? Doxepin tablets can cause serious side effects including: After taking doxepin tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with doxepin tablets. Reported activities include: driving a car ("sleep-driving") making and eating food talking on the phone having sex sleep-walking Stop taking doxepin tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking doxepin tablets. Important: Take doxepin tablets exactly as prescribed Do not take more doxepin tablets than prescribed. Take doxepin tablets 30 minutes before bedtime. After taking doxepin tablets, you should only do activities needed to get ready for bed. What are doxepin tablets? Doxepin Tablets are a prescription medicine used to treat adults who have trouble staying asleep.It is not known if doxepin tablets are safe and effective in children. Do not take doxepin tablets if you: are allergic to any of the ingredients in doxepin tablets. See the end of this Medication Guide for a complete list of ingredients in doxepin tablets. take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is an MAOI. have an eye problem called narrow angle glaucoma that is not being treated or have trouble urinating that is severe. Before taking doxepin tablets, tell your healthcare provider about all of your medical conditions, including if you: have a history of depression, mental illness, or suicidal thoughts have severe sleep apnea have kidney or liver problems have a history of drug or alcohol abuse or addiction have a history of glaucoma or trouble urinating that is severe are pregnant or plan to become pregnant. Taking doxepin tablets in the third trimester of pregnancy may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant during treatment with doxepin tablets. Babies born to mothers who take certain medicines, including doxepin tablets, during the third trimester of pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, low muscle tone, feeding problems, and withdrawal symptoms. are breastfeeding or plan to breastfeed. Doxepin can pass into your breast milk and may harm your baby. You should not breastfeed during treatment with doxepin tablets. Talk to your healthcare provider about the best way to feed your baby during treatment with doxepin tablets. Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Doxepin tablets and other medicines may affect each other causing side effects. Doxepin tablets may affect the way other medicines work, and other medicines may affect how doxepin tablets works. Especially tell your healthcare provider if you take: certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathingKnow the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine. How should I take doxepin tablets? Take doxepin tablets exactly as your healthcare provider tells you to take them. Your healthcare provider may change your dose if needed. Take doxepin tablets within 30 minutes of bedtime.After taking doxepin tablets, you should only do activities to get ready for bed. Do not take doxepin tablets within 3 hours of a meal.Doxepin tablets may make you sleepy the next day if taken with or right after a meal. Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days.This may mean that there is another condition causing your sleep problem. If you take too much doxepin tablets, call your healthcare provider or get medical help right away. What should I avoid during treatment with doxepin tablets? You should not drink alcohol or take other medicines that may make you sleepy or dizzy during treatment with doxepin tablets because it may make your sleepiness or dizziness much worse. You should not drive, operate heavy machinery, or do other dangerous activities after taking doxepintablets. You may still feel sleepy the next day after taking doxepin tablets. Do not drive or do other dangerous activities after taking doxepin tablets until you feel fully awake. What are the possible side effects of doxepin tablets? Doxepin tablets can cause serious side effects including: See What is the most important information I should know about doxepin tablets? Risk of suicide and worsening of depression. Worsening of depression, including suicidal thoughts and actions can happen during treatment with doxepin tablets. Call your healthcare provider right away if you have any thoughts of suicide, dying, or worsening depression. The most common side effects of doxepin tablets include: drowsiness or tiredness nausea upper respiratory tract infection Doxepin tablets may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of doxepin 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 doxepin tablets? Store doxepin tablets at room temperature between 20 to 25 C(68 to 77 F). Protect from light. Keep doxepin tablets and all medicines out of the reach of children. General Information about the safe and effective use of doxepin tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use doxepin tablets for a condition for which they were not prescribed. Do not give doxepin tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about doxepin tablets that is written for healthcare professionals. What are the ingredients in doxepin tablets? Active Ingredient:doxepin hydrochloride Inactive Ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose. Distributed by: Archis Pharma LLC, 15 Corporate PI S Ste 108 Piscataway, NJ 08854 USA For more information, contact RK Pharma at 1-844-757-4276 (1-844-RKPHARM). The brands listed are trademarks of their respective owners. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2023 PI-DXP-00-a MG-DXP-00-a Code No. 200665
NDC 72819-162-03 Doxepin Tablets 6 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 30 Tablets Archis Pharma Each tablet contains: 6.78 mg doxepin hydrochloride, USP equivalent to 6 mg of doxepin. Usual Dosage: See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20 to 25 C(68 to 77 F) [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Made in USA CL-162-03-00-a Distributed by: Archis Pharma LLC 15 Corporate Place South, Suite 108 Piscataway, NJ 08854 USA Code No.: 200661