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| Product NDC Code | 39328-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Senna |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SYRUP | ||||
| RxCUI drug identifier | 702311 | ||||
| Application Number | M007 | ||||
| Labeler Name | Patrin Pharma, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.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.Directions Shake well before using. Do not exceed maximum dose. Take at bedtime or as directed by a doctor. AGE USUAL DOSE MAXIMUM DOSAGE Adults and children 12 years and older 2-3 teaspoons (10 to 15 mL) once a day 3 teaspoons (15 mL) twice a day 6 to 12 years 1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day 1 1/2 teaspoons (7.5 mL) twice a day 2 to 6 years 1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day 3/4 teaspoon (3.75 mL) once a day under 2 years of age Consult a doctor
| AGE | USUAL DOSE | MAXIMUM DOSAGE |
|---|---|---|
| Adults and children 12 years and older | 2-3 teaspoons (10 to 15 mL) once a day | 3 teaspoons (15 mL) twice a day |
| 6 to 12 years | 1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day | 1 1/2 teaspoons (7.5 mL) twice a day |
| 2 to 6 years | 1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day | 3/4 teaspoon (3.75 mL) once a day |
| under 2 years of age | Consult a doctor | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Chocolate 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.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Senna Sennosides Sennosides Sennosides methylparaben propylene glycol propylparaben water sucrose Senna UD Sennosides Sennosides Sennosides methylparaben propylene glycol propylparaben water sucrose Senna UD 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 - 237 mL Bottle Label NDC 39328-020-08 Senna Syrup Natural Vegetable Laxative 8.8mg/5 mL Alcohol Free • Dye Free 8 fl. oz (237 mL) PATRIN PHARMA PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 39328-120-05 Senna Syrup 8.8 mg/5 mL Shake Well For Institutional Use Only See Insert Lot# xxxxxx Exp: yyyy/mm/dd Patrin Pharma Skokie, IL 60076 Rev 03.0124 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
PRINCIPAL DISPLAY PANEL - 15 mL Cup Label Delivers 15 mL NDC 39328-220-15 Senna Syrup 26.4 mg/15 mL Shake Well For Institutional Use Only See Insert Lot# xxxxxx Exp: mm/dd/yyyy Patrin Pharma Skokie, IL 60076 Rev 02.0823 PRINCIPAL DISPLAY PANEL - 15 mL 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.Drug Facts
Patrin Pharma Skokie, IL 60076 www.patrinpharma.com Rev 01.0122
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 breast feeding
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use laxative products for longer than one week unless directed by a doctor.
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 (800) 936 3088. You may also report serious side effects to this phone number.
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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied A chocolate flavored syrup supplied in the following oral dosage cup: NDC 39328-120-05: NDC 39328-120-50: 5 mL unit dose cup Case contains 50 unit dose cups of 5 mL NDC 39328-220-15: NDC 39328-220-50: 15 mL unit dose cup Case contains 50 unit dose cups of 15 mL
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at controlled room temperature 20-25°C (68-77°F). Excursions permitted 15-30°C (59-86°F). Tamper-Evident: Do not use if foil seal over cup is torn or broken.
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. 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 breast feeding Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
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