Drugplain

Dr. Fibra 3.4 g/1

Psyllium Husk · POWDER · Pharmadel LLC

No Recall History
Plain English

Dr. Fibra is a prescription powder containing psyllium husk at 3.4 g/1, taken oral. Manufactured by Pharmadel LLC.

Key Facts

Brand Name
Dr. Fibra
Generic Name
Psyllium Husk
NDC Code (Product)
55758-418
Manufacturer
Pharmadel LLC
Strength
3.4 g/1
Dosage Form
POWDER
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M007
Marketing Start
06/30/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use244 reports
pain228 reports
exposure during pregnancy218 reports
hypertension212 reports
constipation210 reports
headache210 reports
intentional product misuse194 reports
hyperhidrosis177 reports
joint swelling177 reports
food allergy176 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.

Dosage & Administration

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.

Warnings

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, g

Frequently Asked Questions

What is Dr. Fibra used for?

Dr. Fibra contains Psyllium Husk. It is a powder taken oral. Consult your doctor for specific uses.

Is Dr. Fibra a controlled substance?

Dr. Fibra is not classified as a controlled substance by the DEA.

What is the generic name for Dr. Fibra?

The generic name for Dr. Fibra is Psyllium Husk. There are 12 other brand versions of Psyllium Husk.

What is the NDC code for Dr. Fibra 3.4 g/1?

The NDC (National Drug Code) for Dr. Fibra 3.4 g/1 is 55758-418, listed by Pharmadel LLC.