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| Product NDC Code | 68094-049 | ||||
|---|---|---|---|---|---|
| Drug Name | Senna |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SYRUP | ||||
| RxCUI drug identifier | 702311 | ||||
| Application Number | M007 | ||||
| Labeler Name | Precision Dose, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 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 take preferably at bedtime or as directed by a doctor. Shake Well Before Using. age starting dose maximum dosage Adults and children 12 years and older 2-3 teaspoons once a day 3 teaspoons twice a day Children 6 years to under 12 years 1-1½ teaspoons once a day 1½ teaspoons twice a day Children 2 years to under 6 years ½ - ¾ teaspoon once a day ¾ teaspoon twice a day Children under 2 years ask a doctor ask a doctor
| age | starting dose | maximum dosage |
|---|---|---|
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients flavor chocolate, 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 produces 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 SENNA Sennosides A and B Sennosides A and B 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 - 5 mL Cup Label NDC 68094-049-59 PrecisionDose™ Senna Syrup 8.8 mg/5 mL Pkg: Precision Dose, Inc., S. Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 5 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.Senna Syrup Natural Chocolate Flavor 8.8 mg/5 mL For Hospital Use Only Drug Facts
Alcohol Free, Gluten Free, Natural Vegetable Laxative
Manufactured for: Akron Pharma Inc. Fairfield, NJ 07004 Packaged by: Precision Dose, Inc. South Beloit, IL 61080 For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected] LI1378 Rev. 09/21
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 movements that continues over a period of 2 weeks
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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 1 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 overdose, get medical help or contact a Poison Control Center right away.
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? To Report Adverse Drug Events Call (815) 397-9228
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 fail to have bowel movement after use of laxative. These may indicate a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before 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 NDC 68094-049-62 5 mL per unit dose cup Thirty (30) cups per shipper
Storage and handling
Information about safe storage and handling of the drug product.Other information avoid excessive heat store at room temperature 15°-30°C (59°-86°F)
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 ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel movements that continues over a period of 2 weeks Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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