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| Product NDC Code | 48433-219 | ||||
|---|---|---|---|---|---|
| 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 | part334 | ||||
| Labeler Name | Safecor Health, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredient (in each 5 mL = 1 teaspoonful) 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.1 teaspoonful = 5 mL Directions: Shake well before use Do not exceed recommended dose Age Starting Dose Maximum Dosage Adults and children 12 years of age and over 2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime Children under 12 years of age Ask a doctor Ask a doctor
| 1 teaspoonful = 5 mL | ||
| ||
| Age | Starting Dose | Maximum Dosage |
| Adults and children 12 years of age and over | 2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor | 3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (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: Artificial and natural chocolate flavor, methylparaben, propylparaben, propylene glycol, sucrose and purified water.
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.Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 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 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.———Principal Display Panel——— SAFECOR HEALTH NDC: 48433-219-40 Senna Syrup Qty: 40 8.8 mg Sennosides per 5 mL Lot: 20A0020 Contains 40 (5 mL) Unit Dose Cups Exp: 210203 See monograph for complete drug information. Store at room temperature 15°C to 25°C (59°F to 77°F); excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. This package design is not child resistant. For institutional use only. Shake well before use. GTIN: 00348433219409 SN: 200600019 Pkg By: Safecor Health, LLC Columbus, OH 43204 Exp: 210203 Questions or Comments: Call 1-800-447-1006 Lot: 20A0020 Box Label Unit Dose Cup 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.NDC: 48433-219-05 Senna Syrup 8.8 mg/5 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 02/2020 PN5497
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 • vomiting • noticed a sudden change in bowel movement that continues over a period of 2 weeks
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 this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.
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 • no bowel movement after use of laxative These could be signs of a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health care professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.
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 a period longer than 1 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