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| Product NDC Code | 0121-4967 | ||||
|---|---|---|---|---|---|
| Drug Name | Senna |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 702311 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | PAI Holdings, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per teaspoonful - 5 mL) 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.shake well before use Do not exceed recommended dose Age Starting Dose Maximum dosage Adults and children 12 years and older 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime Under 12 years of age ask a doctor ask a doctor 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: NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.
| Adults and children 12 years and older | 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor | 3 teaspoons in the morning and 3 teaspoons 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 movment 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 CITRIC ACID ACETATE GLYCERIN METHYLPARABEN POTASSIUM SORBATE 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.Delivers 5 mL NDC 0121-4967-05 Senna Syrup 8.8 mg Sennosides/5 mL Natural Vegetable Laxative Package Not Child-Resistant Pharmacutical Associates, Inc. Greenville, SC 29605 SEE DRUG FACTS image description
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.
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? 1-800-845-8210 Distributed By: Pharmaceutical Associates, Inc. Greenville, SC 29605
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 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 sudden changed 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 movemebt after use of laxative. They 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