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Product NDC Code | 0220-2253 | ||||||
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Drug Name | Gelsemium sempervirens |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | PELLET | ||||||
Labeler Name | Boiron | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Tube - Gelsemium sempervirens 30C (**contains 0.443 mg of the active ingredient per pellet) Box - Gelsemium sempervirens 30C HPUS (**contains 0.443 mg of the active ingredient in each pellet) (contains less than 10 -14 mg gelsemine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Tube - Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. Box - Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. Children under 12 years of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Tube - lactose, sucrose Box - lactose, sucrose
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Tube - Apprehension with trembling, headaches* Box - temporarily relieves symptoms of occasional nervous tension such as: apprehension, trembling, headaches, uneasiness, inhibition, worry about upcoming event (public speaking, stage performance), does not affect alertness*
Purpose
Information about the drug product’s indications for use.Box - Relieves apprehension with trembling, headaches
Spl product data elements
Usually a list of ingredients in a drug product.Gelsemium sempervirens GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT SUCROSE LACTOSE, UNSPECIFIED FORM ANHYDROUS LACTOSE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Tube - Do not use if pellet dispenser seal is broken. Contains approx 80 pellets. How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details. Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken. 3 Tubes approx 80 pellets 16 Doses per tube Total 240 pellets How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue. Non drowsy Calms Nervous Tension* Meltaway Pellets *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Tube - Keep out of reach of children. Box - Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Tube - 1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com [email protected] Distributed by Boiron, Inc. Newtown Square, PA 19073 Box - 1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com [email protected] Distributed by Boiron, Inc. Newtown Square, PA 19073
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Tube - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. Box - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
Pregnancy or breast feeding
Pregnancy or Breast feedingTube - If pregnant or breast-feeding, ask a health professional before use Box - If pregnant or breast-feeding, ask a health professional before use
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API