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Product NDC Code | 72090-022 | ||||
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Drug Name | Senna syrup |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | SYRUP | ||||
RxCUI drug identifier | 702311 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Pioneer Life Sciences, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (per 5 mL teaspoon) Sennosides 8.8 mg
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.Directions Shake well before using. Do not exceed maximum dose. Take at bedtime or as directed by a doctor. Age Usual Dose Maximum Dose Adults & children 12 years and older 2-3 teaspoons once a day 3 teaspoons twice a day 6 to 12 years 1 to 1-1/2 teaspoons once a day 1 1/2 teaspoons twice a day 2 to 6 years 1/2 to 3/4 teaspoon once a day 3/4 teaspoon once a day Under 2 years Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Propylene Glycol USP, Methyl Paraben NF, Propyl Paraben NF, Sucrose NF, Chocolate Flavor Artificial & Natural, Brownie Flavor Artificial & Natural.
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.Uses Relieves occasional constipation (irregularity) Generally causes bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna Syrup SENNOSIDES SENNOSIDES SENNOSIDES PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN SUCROSE
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.PL0143-01 GC Senna Syrup 8floz.jpg
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.Other Information store at 20-25°C (68-77°F)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have stomach pain, nausea or vomiting notice a change in bowel habits that last over two weeks are pregnant or breastfeeding
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.Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call + 1 (732) 994-2808 or email [email protected]
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.Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use laxative products for longer than one week unless directed by a doctor.
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