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Product NDC Code | 57237-310 | ||||
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Drug Name | Senna syrup |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 702311 | ||||
Application Number | M007.60 | ||||
Labeler Name | Rising Pharma Holdings, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Senna Syrup (8.8 mg/5 mL) Active ingredient per 5 mL(1 Unit Dose) 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 use do not exceed recommended dose Age Starting Dose Maximum Dose Adults and children over 12 years of age 10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor 15 mL in the morning and 15 mL at bedtime Children under 12 years of age Ask a doctor Ask a doctor
Adults and children over 12 years of age | 10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor | 15 mL in the morning and 15 mL at bedtime |
Children under 12 years of age | Ask a doctor | Ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients flavor, methylparaben, propylene glycol, propylparaben, purified water, and 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.Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Drug Facts Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna Syrup Sennosides SENNOSIDES SENNOSIDES METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER 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.Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 FG-38/Iss.: 04/2023 Lid Label Case Label senna-lid-label senna-case-label
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 right away (1-800-222-1222)
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid is torn or broken
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 1-844-474-7464
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)If pregnant or breast-feeding, ask a healthcare professional before 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 1 week unless directed by a doctor. Ask a doctor before use if you have stomach pain, nausea, or vomiting noticed a change in bowel habits that lasts over two weeks Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition.
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