The Structured Product Labeling dataset contains the most recent drug labeling information submitted to the Food and Drug Administration (FDA) and currently in use.
All labels information are published by DailyMed the official provider of FDA label information.
John Snow Labs Standard End User License Agreement
Last updated:January 20, 2021
This Standard End User License Agreement (“EULA”) applies to customers of John Snow Labs Inc. (as defined below), using any product of John Snow Labs Inc. on John Snow Labs Marketplace as defined below (hereinafter referred to “you”) and John Snow Labs Inc., a Delaware corporation (“John Snow Labs”, “we” or “us”).
By downloading, installing, and/or using (as applicable) any Product of John Snow Labs (as defined below), you automatically agree to be bound by, and use our Products in compliance with, this EULA. This EULA, together with additional terms and conditions and/or policies referenced herein or located on https://www.johnsnowlabs.com and/or conveyed to you by John Snow Labs, is a legally binding contract between you and John Snow Labs.
PLEASE READ THIS EULA CAREFULLY BEFORE PURCHASING, INSTALLING OR USING OUR PRODUCTS MADE AVAILABLE ON JOHN SNOW LABS MARKETPLACE.
We may make changes to this EULA from time to time. When we do so, we will revise the “last updated” date given above. The then-current version of this EULA will supersede all earlier versions. You agree that your continued use of our Products after such changes have been published to our EULA will constitute your acceptance of such revised EULA.
“Products” means products and services of John Snow Labs that you download and use from listings in John Snow Labs Data Library;
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Restrictions
You will access or use our Products solely via John Snow Labs Data Library.
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Fees and Taxes
Your use of the Products is subject to our fees. All fees are given on our website https://www.johnsnowlabs.com. Except as set forth in this EULA, the fees are non-refundable. We are entitled to revise our fees from time to time.
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Term and Termination
This EULA will become effective as of the date of your order of Products and shall be in effect until terminated.
John Snow Labs may suspend or terminate your right to use our Products, if you or your end user’s use of the Products:
is in breach of this EULA;
poses a security risk to our Products;
could adversely impact our systems, the Products or other customers;
could subject us, our affiliates, or any third party to liability; or
could be fraudulent.
We may also suspend or terminate your right to use our Products, if you fail to perform your payment obligations, or you have ceased to operate in the ordinary course, made an assignment for the benefit of creditors or similar disposition of your assets, or become the subject of any bankruptcy, reorganization, liquidation, dissolution or similar proceeding.
We may also suspend or terminate your right to use our Products without any reason upon a relevant 30 days’ written notice to you and will refund the unused fees pre-paid by you for access to the Products for the affected time period (if any). Where your access is suspended or terminated by the breach of this EULA or applicable laws, John Snow Labs will will not provide, or be liable for, any refund.
You will cease use of the Products during any period of suspension, or upon termination of this EULA.
All provisions which by their nature are intended to survive termination shall survive termination of this EULA.
Support
If applicable to your Product, John Snow Labs will provide you with the support services. If you use a trial access, support services are excluded. Under this EULA, our support services exclude any installation, training, maintenance services (including any error corrections, bug fixes, or new releases), technical assistance, consulting services, or other services of any kind. Such services are provided at John Snow Labs’ discretion.
From time to time John Snow Labs can perform updates to our software. If available, such updates may include bug fixes, new features and/or enhancements. You are solely responsible for deploying such updates at your own risk and liability.
Access to our Products
We do not provide you with the equipment to access our Products. You are responsible for all fees charged by third parties related to your access and use of our Products (e.g., charges by Internet service providers).
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Privacy Policy
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Links and Third Party Content
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Proprietary Rights
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The Products, including software, is and remains the exclusive property of John Snow Labs and its licensors. Except for the access and use rights expressly set forth in this EULA, no license or other rights in or to the Products or John Snow Labs trademark(s) and other intellectual property rights therein, are granted to you, and all such licenses and rights are expressly reserved. You will not remove, alter, or obscure any proprietary notices (including copyright and trademark notices) on any portion of our Products or any Content.
Trademarks
“John Snow Labs,” the John Snow Labs logo, and any other product, business or service name or slogan, whether registered or pending, displayed on our Products are trademarks of John Snow Labs, Inc. or its suppliers or licensors, and may not be copied, imitated or used, in whole or in part, without the prior written permission of John Snow Labs or the applicable trademark holder. You may not use any metatags or any other “hidden text” utilizing “John Snow Labs” or any other name, trademark or product, business or service name of John Snow Labs without our prior written permission. In addition, the look and feel of our Products, including all page headers, custom graphics, button icons and scripts, is the service mark, trademark and/or trade dress of John Snow Labs and may not be copied, imitated or used, in whole or in part, without our prior written permission. All other trademarks, pending trademarks, registered trademarks, product names and company names or logos mentioned in our Products are the property of John Snow Labs Inc. and/or their respective owners. Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier, or otherwise does not constitute or imply endorsement, sponsorship, or recommendation thereof by us.
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Legal Notices
Enforcement of this EULA will be governed by the laws of the State of Delaware, excluding its conflict and choice of law principles. The exclusive jurisdiction and venue for any claims arising out of or related to this EULA or your use of the Products will lie in the state and federal courts located in Sussex County, within the State of Delaware, and you irrevocably agree to submit to the jurisdiction of such courts. Our failure to enforce any right or provision in this EULA will not constitute a waiver of such right or provision unless acknowledged and agreed by us in writing. In the event that a court of competent jurisdiction finds any provision of this EULA to be illegal, invalid, or unenforceable, the remaining provisions will remain in full force and effect.
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The Structured Product Labeling dataset includes current drug labeling information like Product Name, Ingredients, Route of Administration, Package description and Indications approved by FDA for marketed products.
The regulations require that the content of labeling be submitted in a form that FDA can process, review, and archive.
Since 1999, FDA has been receiving the electronic content of labeling in Portable Document Format (PDF), and this format has allowed FDA to process, review
and archive the content of labeling.
FDA, working with other parties in HL7 (experts from HL7, industry, and technology solution providers), has adapted CDA for labeling in an HL7 standard called Structured Product Labeling (SPL). When compared with PDF, SPL exhibits the following advantages.
– SPL allows the exchange of information between computer systems in a way that cannot be accomplished with PDF. For example, the information in SPL can be used to support health information technology initiatives for improving patient care.
– The exchange of labeling changes with SPL can be easier and more efficient for both FDA and manufacturers when compared with PDF. For example, with SPL, only those sections or data elements of the labeling that are changed would need to be checked rather than the entire labeling.
– SPL allows automation of comparison of text by section and comparison of specific drug information data elements.
– SPL can also be used to exchange information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency.
About this Dataset
Data Info
Date Created
2006-01
Last Modified
2025-03-19
Version
2025-03
Update Frequency
Monthly
Temporal Coverage
N/A
Spatial Coverage
United States
Source
John Snow Labs; DailyMed, National Library of Medicine (NLM);
Source License URL
Source License Requirements
N/A
Source Citation
N/A
Keywords
Structured Product Labeling, FDA Drug Labeling Information, Product Labeling, SPL, DailyMed
Other Titles
DailyMed Drugs Labeling, FDA Approved Drugs Labeling
Data Fields
Name
Description
Type
Constraints
Product_Name
The Name of the product
string
-
Product_Type
Product type (Human/Animal, OTC/Prescription...)
string
-
Ingredients
List of the ingredients of the product
string
-
Route_Of_Administration
Route of Administration of the product
string
-
Appearance_Shape
Shape of the product (unit)
string
-
Appearance_Size
Size of the product (unit)
string
-
Appearance_Score
Product Characteristics: score
string
-
Package_Description
Package Description of the product
string
-
Dosage_Form
Dosage Form of the Product
string
-
Indications
Indications and Usage of the product
string
-
Contraindications
Contraindications of the product
string
-
Controlled_Substance_Code
Controlled Substance Code in the product if included
Promethazine Hydrochloride Tablets, USP are available as follows: 12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000. 25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500. 50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.
Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.
Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
Nitrogen
HUMAN PRESCRIPTION DRUG
Nitrogen995mL
ENDOSINUSIAL
160 L in 1 DEWAR;180 L in 1 DEWAR;230 L in 1 DEWAR;240 L in 1 DEWAR;396 L in 1 CYLINDER;654 L in 1 CYLINDER;2265 L in 1 CYLINDER;3257 L in 1 CYLINDER;6514 L in 1 CYLINDER;5609 L in 1 CYLINDER
20 in 1 BOTTLE;30 in 1 BOTTLE;45 in 1 BOTTLE;56 in 1 BOTTLE;60 in 1 BOTTLE;90 in 1 BOTTLE
Nabumetone Tablets are available as light yellow, oval shaped, film coated, unscored tablets, debossed âP649â on one side and â500â on the other side containing 500 mg of nabumetone, packaged in bottles of 100 (NDC 49884-649-01) and 500 (NDC 49884-649-05) tablets. Nabumetone Tablets are available as dark yellow, oval shaped, film coated, unscored tablets, debossed âP650âon one side and â750â on the other side containing 750 mg of nabumetone, packaged in bottles of 100 (NDC 49884-650-01) and 500 (NDC 49884-650-05) tablets. PHARMACIST: Dispense in a well-closed, light-resistant container as defined in the USP. Use child-resistant closure (as required). Important:Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser. Store at 25°C (77°F); excursions permitted to 15 â 30°C (59-86°F) in well-closed container; dispense in light resistant container
Carefully consider the potential benefits and risks of nabumetone and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
PREDNISONE
HUMAN PRESCRIPTION DRUG
PREDNISONE10mg
ORAL
ROUND
9 mm
2.0
21 in 1 BLISTER PACK;24 in 1 BLISTER PACK;1 in 1 CARTON;2 in 1 CARTON
Prednisone Tablets USP, 5 mg: White, round tablets, scored on one side and âWest-ward 475â debossed on the other side. Each tablet contains 5 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-733-21 Blister Pack of 48 tablets NDC# 45802-733-67 Prednisone Tablets USP, 10 mg: White, round tablets, scored on one side and âWest-ward 473â debossed on the other side. Each tablet contains 10 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-303-21 Blister Pack of 48 tablets NDC# 45802-303-67 Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: West-ward Pharmaceutical Corporation Eatontown, NJ 07724 DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 PREDNISONE TABLETS Revised 09/07 0P800 RC J4
Prednisone tablets are indicated in the following conditions: Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory diseases: symptomatic sarcoidosis, Loefflerâs syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic disorders: Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, eythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephritic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.
Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.
Clotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 à 45) gram tubes. Store between 2°- 30°C (36°- 86°F). CAUTION: Federal law prohibits dispensing without prescription. Mfd. by: TARO Pharmaceuticals Inc., Bramalea, Ontario, Canada L6T 1C3 Revision Date: June, 1996
Clotrimazole Cream is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.
Clotrimazole Cream is contraindicated in individuals sensitive to its components.
Oral-B Minute-Foam Orang-A-Tangy
HUMAN PRESCRIPTION DRUG
SodiumFluoride10mg,HydrofluoricAcid2.3mg
DENTAL
165 g in 1 BOTTLE
HOW SUPPLIED: Minute-Foam is available in a 165 g (5.8 oz) plastic aerosol container in six different flavors; NDC 0041-0340-06 Banana Splitz, NDC 0041-03141-06 Mellow Mint, NDC 0041-0342-06 Orang-a-Tangy, NDC 0041-0345-06 Bubblegum, NDC 0041-0346-06 Strawberry, NDC 0041-0347-06 Grape Punch.
INDICATIONAND USE: A topically-appliedfoaming solution to aid in the prevention of dental caries.
CONTRAINDICATIONS: Do not use in patients with hypersensitivityto fluoride. Do not use in patients withdysphagia.
30 in 1 BOTTLE, PLASTIC;60 in 1 BOTTLE, PLASTIC;90 in 1 BOTTLE, PLASTIC
Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed âMâ and the other side and scored on the other side debossed "58/59". They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only. Manufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846 This Product was Repackaged By Sandhills Packaging for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite AFlowood, MS 39232United States
Metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic or other anemias. Significantly impaired renal or hepatic function.
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants and have been reported with this class of drug in combination with alcohol. When determining the LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes. Treatment Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.
30 in 1 BOTTLE;60 in 1 BOTTLE;120 in 1 BOTTLE;180 in 1 BOTTLE
Sucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of: Tablets are debossed âBIOCRAFTâ on one side and â105â twice on the scored side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 5/2007 Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146
Sucralfate is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
There are no known contraindications to the use of sucralfate.
VERAMYST Nasal Spray, 27.5 mcg per spray, is supplied in a brown glass bottle enclosed in a nasal device with a nozzle and a mist-release button to actuate the spray in a box of 1 (NDC 54868-6168-0) with FDA-Approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 10 g of white, liquid suspension and will provide 120 metered sprays. After priming [see Dosage and Administration (2)], each spray delivers a fine mist containing 27.5 mcg of fluticasone furoate in 50 microliters of formulation through the nozzle. The contents of the bottle can be viewed through an indicator window. Shake the contents well before each use. The correct amount of medication in each spray cannot be assured before the initial priming and after 120 sprays have been used, even though the bottle is not completely empty. The nasal device should be discarded after 120 sprays have been used. Store the device in the upright position with the cap in place between 15° and 30°C (59° and 86°F). Do not freeze or refrigerate.
VERAMYST® (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
VERAMYST Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3)] .
Demos
