6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 interference with urinary normetanephrine measurements use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, n-acetylaminosalicylic acid. consider an alternative, selective assay for normetanephrine [see warnings and precautions (5.8) ] .

, and use a broad-spectrum sunscreen when outdoors. ( 5.6 ) nephrolithiasis: mesalamine-containing stones are undetectable by standard radiography or computed tomography (ct). ensure adequate hydration during treatment. ( 5.7 ) interaction with laboratory test for urinary normetanephrine: spuriously elevated test results may occur with liquid chromatography with electrochemical detection in patients receiving mesalamine; use alternative, selective assay for normetanephrine. ( 5.8 ) 5.1 renal impairment renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as mesalamine rectal suppositories that contain mesalamine or are converted to mesalamine. in animal studies, the kidney was the principal organ of mesalamine toxicity [see adverse reactions (6.2) , nonclinical toxicology (13.2) ] . evaluate renal function prior to initiation of mesalamine and periodically while on therapy. evaluate the risks and benefits of using mesalamine in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs [see drug interactions (7.1) , use in specific populations (8.6) ] . 5.2 mesalamine-induced acute intolerance syndrome mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, malaise, pruritus, conjunctivitis, and rash. monitor patients for worsening of these symptoms while on treatment. if acute intolerance syndrome is suspected, promptly discontinue treatment with mesalamine. 5.3 hypersensitivity reactions hypersensitivity reactions have been reported in patients taking sulfasalazine. some patients may have a similar reaction to mesalamine or to other compounds that contain or are converted to mesalamine. as with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. discontinue mesalamine if an alternative etiology for the signs and symptoms cannot be established. 5.4 hepatic failure there have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. evaluate the risks and benefits of using mesalamine in patients with known liver impairment. 5.5 severe cutaneous adverse reactions severe cutaneous adverse reactions, including stevens-johnson syndrome (sjs) and toxic epidermal necrolysis (ten), drug reaction with eosinophilia and systemic symptoms (dress), and acute generalized exanthematous pustulosis (agep) have been reported in association with the use of mesalamine [see adverse reactions (6.2) ] . discontinue mesalamine at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.6 photosensitivity in patients treated with mesalamine or sulfasalazine who have pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. 5.7 nephrolithiasis cases of nephrolithiasis have been reported with the use of mesalamine, including stones of 100% mesalamine content. mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (ct). ensure adequate hydration during treatment with mesalamine. 5.8 interaction with laboratory test for urinary normetanephrine use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, n-acetylaminosalicylic acid. consider an alternative, selective assay for normetanephrine.

ics, flooring, painted surfaces, marble, granite, vinyl, and enamel. keep mesalamine rectal suppositories away from these surfaces to prevent staining. dosage the recommended adult dosage is 1,000 mg administered rectally once daily at bedtime for 3 to 6 weeks. safety and effectiveness beyond 6 weeks have not been established. ( 2 ) administration instructions: evaluate renal function prior to initiation of mesalamine rectal suppositories and periodically while on therapy. ( 2 , 5.1 ) do not cut or break the suppository. ( 2 ) drink an adequate amount of fluids. ( 2 , 5.7 ) retain the suppository for one to three hours or longer, if possible. ( 2 ) mesalamine rectal suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. keep mesalamine rectal suppositories away from these surfaces to prevent staining. ( 2 )

y compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. the most common adverse reactions in adult patients with mildly to moderately active ulcerative proctitis in double-blind, placebo-controlled trials are summarized in the table 1 below. table 1: adverse reactions occurring in more than 1% of mesalamine suppository treated patients (comparison to placebo) symptom mesalamine (n = 177) placebo (n = 84) n % n % dizziness 5 3 2 2.4 rectal pain 3 1.8 0 0 fever 2 1.2 0 0 rash 2 1.2 0 0 acne 2 1.2 0 0 colitis 2 1.2 0 0 in a multicenter, open-label, randomized, parallel group study in 99 patients comparing the mesalamine 1,000 mg suppository administered nightly to that of the mesalamine 500 mg suppository twice daily. the most common adverse reactions in both groups were headache (14%), flatulence (5%), abdominal pain (5%), diarrhea (3%), and nausea (3%). three (3) patients discontinued medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication. the recommended dosage of mesalamine is 1,000 mg administered rectally once daily at bedtime [see dosage and administration (2) ] . 6.2 post-marketing experience the following adverse reactions have been identified during post-approval use of mesalamine or other mesalamine-containing products. 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. body as a whole: drug fever, fatigue, lupus-like syndrome, medication residue cardiac disorders: myocarditis, pericarditis, pericardial effusion [see warnings and precautions (5.3) ] endocrine: nephrogenic diabetes insipidus eye disorders: eye swelling gastrointestinal disorders: abdominal cramps, abdominal distension, anal pruritus, anorectal discomfort, constipation, feces discolored, flatulence, frequent bowel movements, gastrointestinal bleeding, mucus stools, nausea, painful defecation, pancreatitis, proctalgia, rectal discharge, rectal tenesmus, stomach discomfort, vomiting hepatic disorders: cholestatic jaundice, hepatitis, jaundice, kawasaki-like syndrome including changes in liver enzymes, liver necrosis, liver failure hematologic disorders: agranulocytosis, aplastic anemia, thrombocytopenia neurological/psychiatric disorders: guillain-barre syndrome, peripheral neuropathy, transverse myelitis, intracranial hypertension renal disorders: interstitial nephritis, renal failure, minimal change disease, nephrolithiasis [see warnings and precautions (5.1 , 5.7) ] respiratory, thoracic and mediastinal disorders: hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis), pleuritis/pleurisy skin and subcutaneous tissue disorder: alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria, sjs/ten, dress and agep [see warnings and precautions (5.5) ] urogenital: reversible oligospermia

6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 interference with urinary normetanephrine measurements use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, n-acetylaminosalicylic acid. consider an alternative, selective assay for normetanephrine [see warnings and precautions (5.8) ] .

e recommended human intra-rectal dose of mesalamine, based on body surface area) and in rabbits at oral doses up to 495 mg/kg/day (about 5.4 times the recommended human intra-rectal dose of mesalamine, based on body surface area) following administration during the period of organogenesis, and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. 8.2 lactation risk summary mesalamine and its n-acetyl metabolite are present in human milk in undetectable to small amounts (see data) . there are limited reports of diarrhea in breastfed infants. there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of mesalamine to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine and any potential adverse effects on the breastfed child from mesalamine or from the underlying maternal conditions. clinical considerations monitor breastfed infants for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. the concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/l. the concentration of the n-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of n-acetyl-5-aminosalicylic acid. 8.4 pediatric use the safety and effectiveness of mesalamine rectal suppositories in pediatric patients for the treatment of mildly to moderately active ulcerative proctitis have not been established. mesalamine was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age, which only included 14 patients with histologically-confirmed cases of ulcerative proctitis. however, efficacy was not demonstrated. adverse reactions seen in pediatric patients in this trial (abdominal pain, headache, pyrexia, pharyngolaryngeal pain, diarrhea and vomiting) were similar to those seen in adult patients. 8.5 geriatric use clinical trials of mesalamine did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients receiving mesalamine-containing products such as mesalamine who were 65 years or older compared to younger patients. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing mesalamine [see use in specific populations (8.6) ] . 8.6 renal impairment mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions [see warnings and precautions (5.1), drug interactions (7.1) and adverse reactions (6.2) ] .

recommended human intra-rectal dose of mesalamine, based on body surface area) following administration during the period of organogenesis, and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine.

um steady-state plasma concentration (c min ) was 89 ng/ml (cv=89%). absorbed mesalamine does not accumulate in the plasma. distribution mesalamine administered as a rectal suppository distributes in rectal tissue to some extent. elimination in patients with ulcerative proctitis treated with mesalamine 500 mg as a rectal suppository every 8 hours for 6 days, the mean elimination half-life was 5 hours (cv=73%) for 5-asa and 5 hours (cv=63%) for n-acetyl-5-asa, the active metabolite, following the initial dose. at steady-state, the mean elimination half-life was 7 hours for both 5-asa and n-acetyl-5-asa (cv=102% for 5- asa and 82% for n-acetyl-5-asa). metabolism the absorbed mesalamine is extensively metabolized, mainly to n-acetyl-5-asa in the liver and in the gut mucosal wall. in patients with ulcerative colitis treated with one mesalamine 500 mg rectal suppository every eight hours for six days, the peak concentration (c max ) of n-acetyl-5-asa ranged from 467 ng/ml to 1399 ng/ml following the initial dose and from 193 ng/ml to 1304 ng/ml at steady-state. excretion mesalamine is eliminated from plasma mainly by urinary excretion, predominantly as n-acetyl-5-asa. in patients with ulcerative proctitis treated with mesalamine 500 mg as a rectal suppository every 8 hours for 6 days, 12% or less of the dose was eliminated in urine as unchanged 5-asa and 8% to 77% was eliminated as n-acetyl-5-asa following the initial dose. at steady-state, 11% or less of the dose was eliminated in the urine as unchanged 5-asa and 3% to 35% was eliminated as n-acetyl-5-asa.

nd n-acetyl-5-asa (cv=102% for 5- asa and 82% for n-acetyl-5-asa). metabolism the absorbed mesalamine is extensively metabolized, mainly to n-acetyl-5-asa in the liver and in the gut mucosal wall. in patients with ulcerative colitis treated with one mesalamine 500 mg rectal suppository every eight hours for six days, the peak concentration (c max ) of n-acetyl-5-asa ranged from 467 ng/ml to 1399 ng/ml following the initial dose and from 193 ng/ml to 1304 ng/ml at steady-state. excretion mesalamine is eliminated from plasma mainly by urinary excretion, predominantly as n-acetyl-5-asa. in patients with ulcerative proctitis treated with mesalamine 500 mg as a rectal suppository every 8 hours for 6 days, 12% or less of the dose was eliminated in urine as unchanged 5-asa and 8% to 77% was eliminated as n-acetyl-5-asa following the initial dose. at steady-state, 11% or less of the dose was eliminated in the urine as unchanged 5-asa and 3% to 35% was eliminated as n-acetyl-5-asa.

3.2 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and at intravenous doses of >214 mg/kg (about 1.2 times the recommended human intra-rectal dose of mesalamine, based on body surface area). in a 13-week oral gavage toxicity study in rats, papillary necrosis and/or multifocal tubular injury were observed in males receiving 160 mg/kg (about 0.86 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and in both males and females at 640 mg/kg (about 3.5 times the recommended human intra-rectal dose of mesalamine, based on body surface area). in a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration of the kidneys and hyalinization of basement membranes and bowman’s capsule were observed at oral doses of 100 mg/kg/day (about 0.54 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and above. in a 14-day rectal toxicity study of mesalamine suppositories in rabbits, intra-rectal doses up to 800 mg/kg (about 8.6 times the recommended human intra-rectal dose of mesalamine, based on body surface area) was not associated with any adverse effects. in a six-month oral toxicity study in dogs, doses of 80 mg/kg (about 1.4 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and higher caused renal pathology similar to that described for the rat. in a rectal toxicity study of mesalamine suppositories in dogs, a dose of 166.6 mg/kg (about 3 times the recommended human intra-rectal dose of mesalamine, based on body surface area) produced chronic nephritis and pyelitis. in the 12-month eye toxicity study in dogs, keratoconjunctivitis sicca (kcs) occurred at oral doses of 40 mg/kg (about 0.72 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and above.

stool frequency, mucosal appearance at endoscopy, and a physician’s global assessment of disease. patients were evaluated clinically and sigmoidoscopically after 3 and 6 weeks of treatment. compared to placebo, mesalamine suppositories were statistically (p<0.01) superior to placebo in both trials with respect to improvement in stool frequency, rectal bleeding, mucosal appearance, disease severity, and overall disease activity after 3 and 6 weeks of treatment. the effectiveness of mesalamine suppositories was statistically significant irrespective of sex, extent of proctitis, duration of current episode, or duration of disease. an additional multicenter, open-label, randomized, parallel group study in 99 patients diagnosed with mildly to moderately ulcerative proctitis compared 1,000 mg mesalamine administered rectally once daily at bedtime (n=35) to 500 mg mesalamine suppository administered rectally twice daily, in the morning and at bedtime (n=46), for 6 weeks. the primary measures of efficacy included the clinical disease activity index (dai) and histologic evaluations. patients were evaluated clinically and sigmoidoscopically at 3 and 6 weeks of treatment. the efficacy at 6 weeks was not different between the treatment groups. both were effective in the treatment of ulcerative proctitis and resulted in a significant decrease at 6 weeks in dai: in the mesalamine 500 mg twice daily group, the mean dai value decreased from 6.6 to 1.6, and in the 1,000 mg at bedtime group, the mean dai value decreased from 6.2 to 1.3, which represents a decrease of greater than 75% in both groups. after 6 weeks of treatment, a dai score of less than 3 was achieved in 78% of patients in the mesalamine 500 mg twice daily group and 86% of patients in the mesalamine 1,000 mg once daily group. the recommended dosage of mesalamine is 1,000 mg administered rectally once daily at bedtime [see dosage and administration (2) ] .

periodic monitoring of renal function will be performed while they are on therapy. advise patients to complete all blood tests ordered by their healthcare provider [see warnings and precautions (5.1) , drug interactions (7.1) ] . mesalamine-induced acute intolerance syndrome and other hypersensitivity reactions inform patients of the signs and symptoms of hypersensitivity reactions. instruct patients to stop taking mesalamine and report to their healthcare provider if they experience new or worsening symptoms acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, malaise, conjunctivitis and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see warnings and precautions (5.2 , 5.3 )] . hepatic failure inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms [see warnings and precautions (5.4) ] . severe cutaneous adverse reactions inform patients of the signs and symptoms of severe cutaneous adverse reactions. instruct patients to stop taking mesalamine and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or any other sign of hypersensitivity [see warnings and precautions (5.5) ] . photosensitivity advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see warnings and precautions (5.6) ] . nephrolithiasis instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [see warnings and precautions (5.7) ] . blood disorders inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. advise patients to complete all blood tests ordered by their healthcare provider [see drug interactions (7.2) , use in specific populations (8.5) ] . distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 11-2021-02

the sac around your heart (pericarditis). have liver problems. are pregnant or plan to become pregnant. it is not known if mesalamine rectal suppositories can harm your unborn baby. are breastfeeding or plan to breastfeed. mesalamine can pass into your breast milk. talk to your doctor about the best way to feed your baby if you use mesalamine rectal suppositories. tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. using mesalamine rectal suppositories with certain other medicines may affect each other. using mesalamine rectal suppositories with other medicines can cause serious side effects. especially tell your doctor if you take nonsteroidal anti-inflammatory drugs (nsaids), or medicines that contain azathioprine or 6-mercaptopurine. taking mesalamine rectal suppositories with nsaids may cause kidney problems. taking mesalamine rectal suppositories with azathioprine or 6-mercaptopurine may cause blood problems. ask your doctor if you are not sure if you are taking one of these medicines. your doctor may do certain tests during treatment with mesalamine rectal suppositories. know the medicines you take. keep a list of them to show your doctor and pharmacist when you get a new medicine. how should i take mesalamine rectal suppositories? use mesalamine rectal suppositories exactly as prescribed by your doctor. your doctor will tell you how long to continue using mesalamine rectal suppositories. mesalamine rectal suppositories come as a suppository that you insert into your rectum. do not cut or break the suppository. use mesalamine rectal suppositories 1 time each day at bedtime, for 3 to 6 weeks. it is not known if mesalamine rectal suppositories are safe and effective for use for longer than 6 weeks. after you insert mesalamine rectal suppositories in your rectum, try to keep (retain) the suppository in your rectum for 1 to 3 hours or longer if possible. it is important for you to stay well hydrated during treatment with mesalamine rectal suppositories. be sure to drink plenty of fluids while taking mesalamine rectal suppositories. if you miss a dose of mesalamine rectal suppositories, insert it as soon as you remember. if it is almost time for your next dose, skip the missed dose. insert the next dose at your regular time. do not insert 2 doses at the same time. mesalamine rectal suppositories can stain surfaces including clothing and other fabrics, flooring, painted surfaces, marble, granite, vinyl and enamel. keep mesalamine rectal suppositories away from these surfaces to prevent staining. what are the possible side effects of mesalamine rectal suppositories? mesalamine rectal suppositories may cause serious side effects, including: kidney problems. your doctor will do certain tests before you start using mesalamine rectal suppositories and during your treatment with mesalamine rectal suppositories. acute intolerance syndrome and other allergic reactions. some people who use mesalamine rectal suppositories can have allergic type reactions, including acute intolerance syndrome. other allergic reactions can cause heart problems including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body including the kidneys, liver and lungs. these problems usually happen in people who have had an allergic reaction to medicines containing sulfasalazine. stop using mesalamine rectal suppositories and tell your doctor right away if you get any of these symptoms: cramps fever stomach (abdominal) pain headache bloody diarrhea rash chest pain shortness of breath decrease in the amount of urine fatigue eye inflammation liver problems. this can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. tell your doctor right away if you get any of these symptoms while using mesalamine rectal suppositories: yellowing of your eyes flu-like symptoms itchy skin nausea or vomiting feeling very tired serious skin reactions. some people who use mesalamine rectal suppositories can have severe skin reactions. stop using mesalamine rectal suppositories and tell your doctor right away if you develop any of the following signs or symptoms of a severe skin reaction, including: blisters or peeling of your skin high fever or flu-like symptoms mouth sores enlarged lymph nodes blisters on your lips, or around your mouth or eyes skin rash sun sensitivity. mesalamine rectal suppositories can make your skin sensitive to the sun if you have skin conditions such as atopic dermatitis and atopic eczema. try to limit your time in the sun. you should use sunscreen and wear a hat and clothes that cover your skin if you have to be in the sunlight. kidney stones. drink plenty of fluids when using mesalamine rectal suppositories to decrease your chance of getting kidney stones. call your doctor right away if you get any of these symptoms: severe pain in your side blood in your urine severe pain in your back the most common side effects of mesalamine rectal suppositories include: dizziness rectal pain acne fever inflammation of the large intestine (colitis) rash these are not all of the possible side effects of mesalamine rectal suppositories. 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 mesalamine rectal suppositories? store mesalamine rectal suppositories at room temperature between 68°f to 77°f (20°c to 25°c). mesalamine rectal suppositories may be refrigerated. keep mesalamine rectal suppositories away from direct heat, light, or humidity. keep mesalamine rectal suppositories and all medicines out of the reach of children. general information about the safe and effective use of mesalamine rectal suppositories. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use mesalamine rectal suppositories for a condition for which it was not prescribed. do not give mesalamine rectal suppositories to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about mesalamine rectal suppositories that is written for health professionals. what are the ingredients in mesalamine rectal suppositories? active ingredients : mesalamine, usp inactive ingredients : hard fat base this patient information has been approved by the u.s. food and drug administration distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 11-2021-02