Canada - English - Health Canada

odan laboratories ltd - citric acid; magnesium oxide; sodium picosulfate - powder for solution - 12g; 3.5g; 10mg - citric acid 12g; magnesium oxide 3.5g; sodium picosulfate 10mg - cathartics and laxatives

Canada - English - Health Canada

odan laboratories ltd - citric acid; magnesium oxide; sodium picosulfate - powder for solution - 12g; 3.5g; 10mg - citric acid 12g; magnesium oxide 3.5g; sodium picosulfate 10mg - cathartics and laxatives

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)

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

braintree laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium cation - unii:lyr4m0nh37), potassium sulfate (unii: 1k573lc5tv) (potassium cation - unii:295o53k152), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate 17.5 g in 1 ml - suprep bowel prep kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. suprep bowel prep kit 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 suprep bowel prep kit risk summary there are no available data on suprep bowel prep kit 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 (suprep bowel prep kit). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies

Israel - English - Ministry of Health

pharma shalom - aluminium oxide hydrated; dimethicone; magnesium hydroxide - chewable tablets - magnesium hydroxide 200 mg; dimethicone 25 mg; aluminium oxide hydrated 200 mg - combinations - antacid, antiflatulent, relief of sensation of heartburn.

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

major pharmaceuticals - aluminum hydroxide (unii: 5qb0t2iun0) (aluminum hydroxide - unii:5qb0t2iun0), dimethicone (unii: 92ru3n3y1o) (dimethicone - unii:92ru3n3y1o), magnesium hydroxide (unii: nbz3qy004s) (hydroxide ion - unii:9159uv381p, magnesium cation - unii:t6v3lhy838) -

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

evofem, inc. - lactic acid, l- (unii: f9s9ffu82n) (lactic acid, l- - unii:f9s9ffu82n), citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl), potassium bitartrate (unii: npt6p8p3uu) (tartaric acid - unii:w4888i119h) - phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. limitations of use phexxi is not effective for the prevention of pregnancy when administered after intercourse [see dosage and administration (2.1)]. risk summary there is no use for phexxi in pregnancy; therefore, discontinue phexxi during pregnancy. there are no data with the use of phexxi in pregnant women or animals. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary there are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. the safety and effectiveness of phexxi have been established in females of reproductive potential. efficacy is expected to be the same for post-menarchal females

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

braintree laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - sutab is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. sutab is contraindicated in the following conditions: - gastrointestinal obstruction or ileus [see warnings and precautions ( 5.6) - bowel perforation [see warnings and precautions ( 5.6) - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any ingredient in sutab  [see warnings and precautions ( 5.7) and description ( 11)] risk summary there are no available data on sutab use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. no reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (sutab). 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.

Malta - English - Medicines Authority

opella healthcare france sas t/a sanofi 157 avenue charles de gaulle, 92200 neuilly-sur-seine , france - simethicone, aluminium hydroxide, magnesium hydroxide - oral suspension - magnesium hydroxide 200 mg simethicone 25 mg aluminium hydroxide 175 mg - drugs for acid related disorders

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - citric acid 12 g;  ; light magnesium oxide 3.5 g; sodium picosulfate 10mg - powder for oral solution - active: citric acid 12 g   light magnesium oxide 3.5 g sodium picosulfate 10mg excipient: orange flavour 655280 potassium bicarbonate saccharin sodium - for clearance of the bowel prior to examination by radiography, endoscopy or surgery.