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| Product NDC Code | 55758-418 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr. fibra |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | POWDER | ||||
| RxCUI drug identifier | 824586 | ||||
| Application Number | M007 | ||||
| Labeler Name | Pharmadel LLC | ||||
| 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 and Purpose Active ingredient (in each packet) Purpose Psyllium seed husk 3.4 g.................... Bulk-forming laxative
| Psyllium seed husk 3.4 g.................... | Bulk-forming 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.Directions mix this product (child or adult dose) 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. adults and children 12 years of age and older 1 packet up to 3 times a day children 6 to under 12 years of age 1/2 packet up to 3 times a day children under 6 years of age consult a doctor First time users: Start with the 1 packet per day, gradually increase to 3 times a day, as necessary. As your body adjust to increased fiber intake, you may experience changes in bowel habits and/or minor bloating.
| 1/2 packet up to 3 times a day | |
| consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, FD&C yellow #6, flavors, povidone k-30, sodium bicarbonate, sucralose
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 For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Active ingredient (in each packet) Purpose Psyllium seed husk 3.4 g.................... Bulk-forming laxative
| Psyllium seed husk 3.4 g.................... | Bulk-forming laxative |
Spl product data elements
Usually a list of ingredients in a drug product.Dr. Fibra Psyllium Husk ANHYDROUS CITRIC ACID SODIUM BICARBONATE FD&C YELLOW NO. 6 POVIDONE K30 PSYLLIUM HUSK PSYLLIUM HUSK SUCRALOSE
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.Principal Display Panel Dr Fibra PDP BOX
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. by: Pharmadel LLC. New Castle, DE 19720
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 abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks a sodium restricted diet
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if allergic to any ingredient in this product
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each packet contains: potassium 36 mg; sodium 178 mg store below 86°F (30°C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
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 • constipation lasts more than 7 days • rectal bleeding occurs • you fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
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.When using this product take this product 2 hours before or after other drugs
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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. Allergy Alert: This product may cause allergic reactions in people, sensitive to inhaled or ingested psyllium. Do not use if allergic to any ingredient in this product Ask a doctor before use if you have abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks a sodium restricted diet Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product take this product 2 hours before or after other drugs Stop use and ask a doctor if • constipation lasts more than 7 days • rectal bleeding occurs • you fail to have a bowel movement after use of a laxative. These may be signs of 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