Otc - Purpose
| Active ingredient (in each packet) | Purpose |
| Psyllium seed husk 3.4 g.................... | Bulk-forming laxative |
Dr. Fibra Powder
FDA Label NDC 55758-418
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dr. Fibra (NDC 55758-418). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
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.
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.
Other Information
- each packet contains: potassium 36 mg; sodium 178 mg
- Store in a cool dry place
- do not use packet if punctured or torn
Inactive Ingredients
anhydrous citric acid, FD&C red #3, FD&C yellow #6, flavors, isopropyl alcohol, povidone k-30, sodium bicarbonate, sucralose, water.
Questions?
+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Dist. By:
Pharmadel LLC.
New Castle, DE 19720
Principal Display Panel
Df_pdp (Drf Pdp)
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