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| Product NDC Code | 71335-2230 | ||||||||||||||||
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| Drug Name | Geri-kot |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||||||
| Dosage Form | TABLET | ||||||||||||||||
| RxCUI drug identifier | 312935 | ||||||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||||||
| Labeler Name | Bryant Ranch Prepack | ||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Sennosides 8.6 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 • do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor
| Age | Starting Dose | Maximum Dose |
|---|---|---|
| adults and children 12 years of age and older | 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor | 4 tablets in the morning and 4 tablets at bedtime |
| children under 12 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, silica, talc, triacetin
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 produces 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.Geri-kot SENNOSIDES MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE TALC TRIACETIN HYPROMELLOSE, UNSPECIFIED SENNOSIDES SENNOSIDES PS23
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 8.6mg Tablet Label
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 overdose, get medical help or contact a Poison Control Center right away.
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 Sennosides 8.6 mg NDC: 71335-2230-1: 100 Tablets in a BOTTLE NDC: 71335-2230-2: 60 Tablets in a BOTTLE NDC: 71335-2230-3: 120 Tablets in a BOTTLE NDC: 71335-2230-4: 56 Tablets in a BOTTLE NDC: 71335-2230-5: 30 Tablets in a BOTTLE NDC: 71335-2230-6: 90 Tablets in a BOTTLE NDC: 71335-2230-7: 10 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 30 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at 20°C-25°C (68°F-77°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 Do not use for more than 1 week unless directed by a doctor. Ask a doctor before use if you • have abdominal pain, nausea or vomiting • have noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a 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 overdose, get medical help or contact a Poison Control Center right away.
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