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| Product NDC Code | 57896-459 | ||||
|---|---|---|---|---|---|
| Drug Name | Fiber laxative |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED | ||||
| RxCUI drug identifier | 308934 | ||||
| Application Number | M007 | ||||
| Labeler Name | Geri-Care Pharmaceutical Corp | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each caplet) Calcium Polycarbophil 625 mg (equivalent to 500 mg polycarbophil)
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 take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. This laxative works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation. adults and children 12 years of age and older Starting dose: 2 caplets once a day Maximum dose: 2 caplets four times a day or as directed by a doctor children under 12 years of age consult a doctor
| adults and children 12 years of age and older | Starting dose: 2 caplets once a day Maximum dose: 2 caplets four times a day or as directed by a doctor |
| children under 12 years of age | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients caramel, cellulose, crospovidone, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium lauryl sulfate, stearic acid
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 promotes regularity this product generally produces a bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Bulk-forming laxative
Spl product data elements
Usually a list of ingredients in a drug product.Fiber Laxative Calcium Polycarbophil LIGHT MINERAL OIL STEARIC ACID CROSPOVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 SILICON DIOXIDE CARAMEL CALCIUM POLYCARBOPHIL POLYCARBOPHIL SODIUM LAURYL SULFATE Caplet CPC;339 Off white to cream
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.Package Label 1
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each caplet contains: calcium 140 mg • store at controlled room temperature, 68°F-77°F (20°C-25°C) • protect contents from moisture Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
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 Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. • Do not take this product if you have difficulty in swallowing. • If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. A sk a doctor before use if you have • abdominal pain, nausea, or vomiting • a sudden change in bowel habits that persists over a period of 2 weeks. Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work. When using this product do not use for more than 7 days unless directed by a doctor do not take more than 8 caplets in a 24 hour period unless directed by a doctor Stop use and ask a doctor if rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition. 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