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seroyal usa - potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg) - potassium sulfate 1 [hp_x] - indications for the temporary relief of dry, itchy skins, minor sore throats, and eye irritation indications for the temporary relief of dry, itchy skins, minor sore throats, and eye irritation directions adults: take five granules three times daily or as recommended by your healthcare practitioner. children: take three granules and follow adult directions.

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lupin pharmaceuticals, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium sulfate oral solution is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. no overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation.

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novel laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium

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

kvk-tech, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate 17.5 g in 22.7 g - colprep kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with colprep kit. it is also not known whether colprep kit can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. colprep kit should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when colprep kit is administered to a nursing woman. the safety and effectiveness of colprep kit have not been established in pediatric patients. of the 375 patients who received another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g)

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strides pharma science limited - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions: - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)] - bowel perforation [see warnings and precaution (5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution risk summary there are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (sodium sulfate, potassium sulfate and magnesium sulfate oral solution). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of 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. risk summary there are no data available data on the presence of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in human or animal milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sodium sulfate, potassium sulfate and magnesium sulfate oral solution and any potential adverse effects on the breastfed child from sodium sulfate, potassium sulfate and magnesium sulfate oral solution or from the underlying maternal condition. the safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in this age group is supported by evidence from an adequate and well-controlled trial of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see clinical studies ( 14)] . in the pediatric trial, sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses). therefore, sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see dosage and administration (2.3)] . the safety profile of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see adverse reactions (6.1)] . the safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in pediatric patients less than 12 years of age have not been established. of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. no overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as the recommended split-dose (2-day) regimen were observed between geriatric patients and younger patients. geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation (not a recommended regimen). elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see warnings and precautions (5.1)] . use sodium sulfate, potassium sulfate and magnesium sulfate oral solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. these patients may be at risk for renal injury. advise these patients of the importance of adequate hydration before, during and after use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and bun) in these patients [see warnings and precautions (5.4)] .

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energique, inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), dibasic potassium phosphate (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium phosphate, dibasic, heptahydrate (unii: 70wt22sf4b) (phosphate ion - unii:nk08v8k8hr), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), calcium sulfate anhydrous (unii: e9 - potassium cation 3 [hp_x] in 1 ml - may temporarily relieve symptoms of impaired cellular function, such as constant thirst.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve symptoms of impaired cellular function, such as constant thirst.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

natural ophthalmics, inc - silicon dioxide (unii: etj7z6xbu4) (silicon dioxide - unii:etj7z6xbu4), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), chelidonium majus whole (unii: 7e889u5rnn) (chelidonium majus whole - unii:7e889u5rnn), physostigma venenosum seed (unii: cjv9e9iioa) (physostigma venenosum seed - unii:cjv9e9iioa), sepia officinalis juice (unii: qdl83wn8c2) (sepia officinalis juice - unii:qdl83wn8c2), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), phosphorus (unii: 27ylu75u4w) (phosphorus - unii:27ylu75u4w) - uses: according to homeopathic indications, these ingredients offer temporary relief for the symptoms of eye floaters.†

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hyland's inc. - potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg) - relief of symptoms of the common cold. relief of symptoms of pimples and blemishes associated with common acne.

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hyland's inc. - calcium sulfate anhydrous (unii: e934b3v59h) (calcium cation - unii:2m83c4r6zb), ferrosoferric phosphate (unii: 91gqh8i5f7) (ferrosoferric phosphate - unii:91gqh8i5f7), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), potassium phosphate, dibasic (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium phosphate, dibasic trihydrate (unii: hf539g9l3q) (magnesium cation - unii:t6v3lhy838), sodium chlo - calcium fluoride 6 [hp_x] - for relief of symptoms of colds, simple nervous tension, fatigue and headaches. for relief of symptoms of colds, simple nervous tension, fatigue and headaches

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plymouth healthcare products llc - potassium bromide (unii: osd78555zm) (bromide ion - unii:952902ix06), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70), oyster shell calcium carbonate, crude (unii: 2e32821g6i) (oyster shell calcium carbonate, crude - unii:2e32821g6i), nickel sulfate hexahydrate (unii: jc9wz4fk68) (nic - potassium bromide 1 [hp_x] - uses: for the temporary relief of dandruff symptoms.** the claims for this product are based upon traditional homeopathic practice. they have not been reviewed by the fda.