FDA Label for Fiber Lax
View Indications, Usage & Precautions
Fiber Lax Product Label
The following document was submitted to the FDA by the labeler of this product Contract Pharmacy Services-pa. 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.
Active Ingredient (In Each Tablet)
Calcium Polycarbophil 625mg (equivalent to polycarbophil 500mg)
Purpose
Bulk-Forming Laxative
Uses
- relieves occasional constipation
- 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 attention.
Do Not Use
for longer than one week
Ask A Doctor Before Use If You Have
-abdominal pain, nausea, or vomiting
-noticed a sudden change in bowel habits that lasts over two weeks
Ask A Doctor Or Pharmacist Before Use If
you are taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop Use And Ask A Doctor If
-you have rectal bleeding
-you fail to have a bowel movement after using this product. These may indicate a serious condition.
Keep Out Of Reach Of Children.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Center right away.
Directions
Take Fiber-Lax 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.
-take dose 1-4 times daily - do not take more than 4 doses in 24 hours.
-adults & children 12 years and over: 2 captabs
-children under 12 years: ask a doctor
Other Information
each captab contains: calcium 140mg
Storage
-store below 30 degrees C (86 degrees F)
-do not refrigerate
-protect from humidity
Inactive Ingredients
Anhydrous lactose, caramel powder, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl and stearic acid.
Questions Or Comments?
Questions and Comments?
Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original--08/2010--NJW
Package Label
Blister of 30
* Please review the disclaimer below.