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Product NDC Code | 71399-8237 | ||||
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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 | part334 | ||||
Labeler Name | Akron Pharma Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active ingredient (in each 5 ml) purpose Sennosides 8.8 mg …………………………................Laxative
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.age starting dose maximum dosage Mulls and children 12 yeart and older 2-3 teaspoons once a day 3 teaspoons twice a day Children 6 years to under 12 yeart 1 -11> teaspoons once a day 11> teaspoons twice a day Children 2 yeart to under 6 yeart l> -¾teaspoon once a day ¾ teaspoon twice a day Children under 2 years ask a doctor ask a doctor
age | starting dose | maximum dosage |
Mulls and children 12 yeart and older | 2-3 teaspoons once a day | 3 teaspoons twice a day |
Children 6 years to under 12 yeart | 1 -11> teaspoons once a day | 11> teaspoons twice a day |
Children 2 yeart to under 6 yeart | l> -¾teaspoon once a day | ¾ teaspoon twice a day |
Children under 2 years | ask a doctor | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Mythylparaben, 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.Directions shake well before use take preferably at bedtime or as directed by a doctor
Purpose
Information about the drug product’s indications for use.Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6 to 12 hours
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.8OZ
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 SECTION In case of accidental overdose, get medical help or contact a Poison Control Center immediately Questions? To Report Adverse Drug Event Call 1(877) 225-6999 Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004
Storage and handling
Information about safe storage and handling of the drug product.Other Information Avoid accessive 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 betore use rt 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 produe1s 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