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| Product NDC Code | 60687-851 | ||||
|---|---|---|---|---|---|
| Drug Name | Senna |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | NM900 | ||||
| Labeler Name | American Health Packaging | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per 5 mL cup) 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 dosage Adults and children 12 years and older 2 to 3 unit dose cups once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 unit dose cups in the morning and 3 unit dose cups at bedtime 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 citric acid, glycerin, methylparaben, potassium sorbate, 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 CITRIC ACID ACETATE GLYCERIN METHYLPARABEN POTASSIUM SORBATE PROPYLPARABEN WATER SUCROSE SENNOSIDES SENNOSIDES
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 – Label – 8.8 mg/5 mL Case NDC 60687-851-77/Cup NDC 60687-851-40 Senna Syrup 8.8 mg Sennosides/5 mL Natural Vegetable Laxative USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) For Institutional Use Only. T0967C050724 R07/24 Senna Syrup Label
Principal Display Panel – Cup Lid – 8.8 mg/5 mL NDC 60687- 851 -40 Senna Syrup Natural Vegetable Laxative 8.8 mg Sennosides/5 mL Delivers 5 mL SHAKE WELL BEFORE USING See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0967C050724 8.8 mg/5 mL Senna Syrup Cup Lid
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.Generic Section DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 R07/24
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 have stomach pain nausea vomiting noticed a change in bowel movement that continues over a period of 2 weeks
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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 room temperature 20° to 25°C (68° to 77°F). a brown, natural flavored syrup supplied in the following oral dosage form: 5 mL unit dose cups: 40 cups (4 x 10) NDC 60687-851-77
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 1-800-845-8210
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 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.
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 or pharmacist before use if you have stomach pain nausea vomiting noticed a change in bowel movement that continues over a period of 2 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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