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acella pharmaceuticals, llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 250 mg in 5 ml - gabapentin oral solution is indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin oral solution is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - hydrocodone bitartrate 5 mg in 5 ml - hydrocodone bitartrate and chlorpheniramine maleate oral solution is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. important limitations of use not indicated for pediatric patients under 18 years of age [see use in specific populations ( 8.4)] . hydrocodone bitartrate and chlorpheniramine maleate oral solution is contraindicated in: - patients with known hypersensitivity to hydrocodone bitartrate, chlorpheniramine maleate or any of the inactive ingredients of hydrocodone bitartrate and chlorpheniramine maleate oral solution. - patients receiving maoi therapy or within 14 days of stopping such therapy. - patients with narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of hydrocodone bitartrate and chlorpheniramine maleate oral solut

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - phenazopyridine hydrochloride (unii: 0ewg668w17) (phenazopyridine - unii:k2j09emj52) - phenazopyridine hydrochloride 200 mg - phenazopyridine hcl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. the use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. the drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. there is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (see dosage and administration.)

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), calcium (unii: sy7q814vup) (calcium - unii:sy7q814vup), ferrous fumarate (unii: r5l488ry0q) (ferrous cation - unii:gw89581owr), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate, dl- (unii: wr1wpi7ew8) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), pyridoxine (unii: kv2jz1bi6z) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), doconexent (unii: zad9okh9jc) (doconexent - unii:zad9okh9jc) - ascorbic acid 28 mg - pnv-dha + docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with dha. each softgel is red in color and imprinted with “323” on one side. † daily value (dv) not established. bovine gelatin, glycerin, soybean oil, soy lecithin, purified water, yellow beeswax, fd&c red # 40, titanium dioxide, orange cream flavor, ethyl vanillin, fd&c yellow # 6, and fd&c blue #1. contains soy. pnv-dha + docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x) - hyoscyamine sulfate 0.125 mg - this product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. it can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. this product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders. glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. this product is not recommended for use in children under twelve years of age.

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x) - hyoscyamine sulfate 0.125 mg - this product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. it can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. this product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders. glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. this product is not recommended for use in children under twelve years of age.

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x) - hyoscyamine sulfate 0.125 mg - this product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. it can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. this product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders. glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. this product is not recommended for use in children under twelve years of age.

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - (to understand fully the indication for this product, please read the entire indication and usage section of the labeling.) ciclopirox topical solution, usp 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to trichophyton rubrum . the comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. - no studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. therefore, the concomitant use of ciclopirox topical solution, 8% and systemic antifungal agents for onychomycosis, is not recommended. - ciclopirox topical solution, 8% should be used only under medical supervision as described above. - the effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. the clinical trials with use of ciclopirox topical solution, 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were hiv seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. patients with severe plantar (moccasin) tinea pedis were also excluded. - the safety and efficacy of using ciclopirox topical solution, 8% daily for greater than 48 weeks have not been established. clinical trials data the results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the us. in these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8%, in conjunction with monthly removal of the unattached, infected toenail by the investigator. ciclopirox topical solution, 8% was applied for 48 weeks. at baseline, patients had 20-65% involvement of the target great toenail plate. statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology) and in two studies for the endpoint “almost clear” ≤10% nail involvement and negative mycology) at the end of study. these results are presented below. *clear nail and negative mycology ** ≤10% nail involvement and negative mycology *** negative koh and negative culture the summary of reported patient outcomes for the itt population at 12 weeks following the end of treatment are presented below. note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. * four patients (from studies 312 and 313) who were completely cured did not have post-treatment week 12 planimetry data. ciclopirox topical solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - benzonatate (unii: 5p4dhs6enr) (benzonatate - unii:5p4dhs6enr) - benzonatate capsules usp are indicated for the symptomatic relief of cough. hypersensitivity to benzonatate or related compounds.

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals, llc - nifedipine (unii: i9zf7l6g2l) (nifedipine - unii:i9zf7l6g2l) - nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by st segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. in those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers. nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who c