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Product NDC Code | 72162-1672 | ||||
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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 | ||||
Labeler Name | Bryant Ranch Prepack | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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.Dosage Age Usual Dose Maximum Dose Adults and Children 12 years and older 2-3 teaspoons once a day 3 teaspoons twice a day 6-12 years 1 to 1 1/2 teaspoons once a day 1 1/2 teaspoons twice a day 2-6 years 1/2 to 3/4 teaspoon once a day 3/4 teaspoons twice a day under 2 years Consult a doctor
Adults and Children 12 years and older | 2-3 teaspoons once a day | 3 teaspoons twice a day |
6-12 years | 1 to 1 1/2 teaspoons once a day | 1 1/2 teaspoons twice a day |
2-6 years | 1/2 to 3/4 teaspoon once a day | 3/4 teaspoons twice a day |
under 2 years | Consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Chocolate flavor, methylparaben, propylene glycol, proylparaben, 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 Syrup Natural Vegetable Laxative SENNOSIDES SENNOSIDES WATER PROPYLENE GLYCOL SUCROSE METHYLPARABEN PROPYLPARABEN
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.Sennosides 8.8 mg Syrup #237 Label
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 2 weeks • are pregnant or breastfeeding.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store at controlled room temperature 20-25°C(68-77°F). Excursions permitted 15-30° (59-86°F). Tamper Evident : Do not use if foil seal over bottle opening is torn, broken or missing.
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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Directions Shake well before using. Do not exceed maximum dose. Take at bedtime or as directed by a doctor.
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 Senna Syrup NaturaL Vegetable Laxative 8.8 mg/5 mL NDC: 72162-1672-2: 237 mL in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
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.Warning Do not use laxative products for longer than 1 week unless directed by a doctor.
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