United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

zanza specials international ltd - pyridoxine hydrochloride - oral tablet - 50mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - pyridoxine hydrochloride - oral tablet - 50mg

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

duchesnay usa, inc. - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - bonjesta is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. limitations of use bonjesta has not been studied in women with hyperemesis gravidarum. bonjesta is contraindicated in women with any of the following conditions: - known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation - monoamine oxidase (mao) inhibitors intensify and prolong the adverse central nervous system effects of bonjesta [see drug interactions (7.1)] . risk summary bonjesta is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. maternal risks are discussed throughout the labeling. no increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. in the u.s. general population, the estimated background risks for major birth defects and miscarriage in clin

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

bionpharma inc., - doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. limitations of use doxylamine succinate and pyridoxine hydrochloride delayed-release tablets havenot been studied in women with hyperemesis gravidarum. doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are contraindicated in women with any of the following conditions: - known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation. - monoamine oxidase (mao) inhibitors intensify and prolong the adverse central nervous system effects of doxylamine succinate and pyridoxine hydrochloride [see drug interactions (7.1)] . risk summary doxylamine succinate and pyridoxine hydrochloride is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. maternal risks are discussed throughout the labeling. no increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. in the u.s. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data human data the combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. a meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride. a second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride. women should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride. the molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of doxylamine succinate and pyridoxine hydrochloride resulting in worsening of their apnea or respiratory conditions. pyridoxine hydrochloride is excreted into breast milk. there have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk. the safety and effectiveness of doxylamine succinate and pyridoxine hydrochloride in children under 18 years of age have not been established. fatalities have been reported from doxylamine overdose in children. the overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest. children appear to be at a high risk for cardiorespiratory arrest. a toxic dose for children of more than 1.8 mg/kg has been reported. a 3-year-old child died 18 hours after ingesting 1,000 mg doxylamine succinate. however, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.

New Zealand - English - Medsafe (Medicines Safety Authority)

multichem nz limited - pyridoxine hydrochloride 50mg (+1.8% (0.9mg) overage);  ;  ;   - tablet - 50 mg - active: pyridoxine hydrochloride 50mg (+1.8% (0.9mg) overage)       excipient: calcium hydrogen phosphate dihydrate colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose

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

nivagen pharmaceuticals, inc. - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - pyridoxine hydrochloride 25 mg - for the dietary management of individuals with distinct nutritional needs under a physician or health-care provider's supervision for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary1 , peripheral2 , or cerebral3 vessels, or vitamin b12 deficiency4 . niva-fol™ tablets are labeled as a medical food intended for use under active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food. known hypersensitivity to any of the components in the product is a contraindication.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eumedica sa-nv - pyridoxine hydrochloride 250 mg - tablet - 250 mg - pyridoxine hydrochloride 250 mg - pyridoxine (vit b6)

Canada - English - Health Canada

pharmascience inc - doxylamine succinate; pyridoxine hydrochloride - tablet (delayed-release) - 10mg; 10mg - doxylamine succinate 10mg; pyridoxine hydrochloride 10mg - miscellaneous antiemetics

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

carwin pharmaceutical associates, llc - vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol, dl- (unii: 7qwa1rio01) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), levomefolic acid (unii: 8s95dh25xc) (levomefolic acid - unii:8s95dh25xc), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), cupric sulfate (unii: lrx7aj16dt) (cupric cation - unii:8cbv67279l), sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - vitamin a 1200 [iu] - quflora™ pediatric chewable tablets with 0.5 mg fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals. quflora™ pediatric chewable tablets with 0.5 mg fluoride should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

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

virtus pharmaceuticals opco ii - ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), biotin (unii: 6so6u10h04) (biotin - ascorbic acid 60 mg - virt-vite plus is contraindicated for persons with a known hypersensitivity to any of its ingredients and those with conditions for which any of the ingredients are contraindicated.