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Product NDC Code | 57237-301 | ||||
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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 | M007.60 | ||||
Labeler Name | Rising Pharma Holdings, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Senna Syrup Active ingredient (in each 5 mL 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 recommended dose Age Starting Dose Maximum Dose adults and children 12 years and older 2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoonfuls in the morning and 3 teaspoonfuls at bedtime Under 12 years of age ask a doctor ask a doctor
adults and children 12 years and older | 2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor | 3 teaspoonfuls in the morning and 3 teaspoonfuls 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: artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, 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 Syrup Sennosides SENNOSIDES SENNOSIDES METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE Brown to dark brown
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.sennalabel01
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 1-844-474-7464
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 15° to 25° C (59° to 77° F) TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.
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 before use if you have stomach pain, nausea or vomitting noticed a change in bowel habits that lasts over two weeks. Stope 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.
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