FDA Label for Dr. Fibra
View Indications, Usage & Precautions
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
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- PRINCIPAL DISPLAY PANEL
Dr. Fibra Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| Active ingredient (in each packet) | Purpose |
| Psyllium seed husk 3.4 g.................... | Bulk-forming laxative |
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
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