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If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. As with all medicines, if you are pregnant or breast feeding , consult a heatlh professional before using this product. Keep out of reach of children . In case of overdose, get medical or contact a Poison Control Center right away. Keep out of reach of children."],"questions":["Distributed By: ProBLEN (888) 326-2121 3021 Ridge Rd., Rockwall, TX 75032 Questions or Comments: www.problen.com"],"effective_time":"20221130","active_ingredient":["Active Ingredients - Equal Amounts Of: Arginine pyroglutamate 12X, Coleus forskohlii 12X, Glutamine 12X, Glycine 12X, Lysine 12X, Mucuna pruriens 12X, Ornithine alpha-ketoglutarate 12X, Tribulus terrestris 12X, Tyrosine 12X, CDP-choline 12X (cytidine5'-diphosphocholine or citicoline), GABA 12X *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"inactive_ingredient":["Inactive Ingredients: Organic Ethanol 20%, Purified water."],"indications_and_usage":["Uses: Temporarily supports the body to rebalance Human Growth Hormone (HGH) output. Symptoms of imbalanced HGH may include: poor muscle/ fat balance, dry wrinkled-looking skin, low energy, sleeplessness, weak immune system.*"],"other_safety_information":["Other Information: Store at room temperature. Tamper Evident: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing."],"dosage_and_administration":["Directions: Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer."],"spl_product_data_elements":["HGH COMPLEX Arginine pyroglutamate, Coleus forskohlii, Glutamine, Glycine, Lysine, Mucuna pruriens, Ornithine alpha-ketoglutarate, Tribulus terrestris, Tyrosine, CDP-choline, GABA ALCOHOL WATER ARGININE PIDOLATE ARGININE PLECTRANTHUS BARBATUS ROOT PLECTRANTHUS BARBATUS ROOT GLUTAMINE GLUTAMINE GLYCINE GLYCINE LYSINE LYSINE MUCUNA PRURIENS SEED MUCUNA PRURIENS SEED DIORNITHINE OXOGLURATE ORNITHINE TRIBULUS TERRESTRIS WHOLE TRIBULUS TERRESTRIS WHOLE TYROSINE TYROSINE CITICOLINE CITICOLINE .GAMMA.-AMINOBUTYRIC ACID .GAMMA.-AMINOBUTYRIC ACID"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"package_label_principal_display_panel":["NDC: 43853-0032-1 HGH COMPLEX HOMEOPATHIC ORGANOTHERAPY 1.0 FL OZ (30mL) 20% ALCOHOL prOBLENopathy 1 oz bottle label Uses: Temporarily supports the body to rebalance Human Growth Hormone (HGH) output."]},"tags":[{"label":"Amino Acid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A16AA03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Powder","category":"form"},{"label":"Active","category":"status"},{"label":"Short bowel syndrome","category":"indication"},{"label":"Emmaus Medcl","category":"company"},{"label":"Approved 2000s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"SICKLE CELL ANAEMIA WITH CRISIS","source":"FDA FAERS","actionTaken":"1638 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"674 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"323 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"302 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION","source":"FDA FAERS","actionTaken":"280 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"260 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"241 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"201 reports"},{"date":"","signal":"HOSPITALISATION","source":"FDA FAERS","actionTaken":"193 reports"},{"date":"","signal":"ABDOMINAL PAIN UPPER","source":"FDA FAERS","actionTaken":"185 reports"}],"commonSideEffects":[],"specialPopulations":{"Lactation":"There are no data on the presence of Endari in human milk, the effect on the breastfed infant or the effect on milk production. The developmental and health benefits from breastfeeding should be considered along with the mothers clinical need for Endari and any potential adverse effects on the breastfed child from Endari or from the underlying maternal condition.","Pregnancy":"There are no available data on Endari use in pregnant women to inform drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with Endari. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated population are unknown. 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.","Geriatric use":"Clinical studies of Endari did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.","Paediatric use":"The safety and effectiveness of Endari have been established in pediatric patients years and older. Use of Endari is supported by evidence from placebo-controlled studies in adult and pediatric patients with sickle cell disease. The clinical studies enrolled 110 pediatric patients in the following age groups: 46 children (5 years up to less than 12 years) and 64 adolescents (12 years to less than 17 years)."}},"trials":[],"aliases":[],"company":"Emmaus Medcl","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GLUTAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:15:16.511681+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:15:22.918722+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA 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