FDA Label for Fiber Lax
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- 16 HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Fiber Lax Product Label
The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, Inc.. 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.
Drug Facts
Active ingredient (in each captab)
Calcium polycarbophil 625 mg
Purpose
Bulk-Forming Laxative
(equivalent to polycarbophil 500 mg)
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 medical attention.
Do Not Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid
Questions Or Comments?
Call 1-800-645-2158
Other
TAMPER EVIDENT: DO NOT USE IF BLISTER SEAL IS BROKEN OR DAMAGED
*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark FiberCon®.
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www. Rugbylaboratories.com
16 How Supplied
Fiber-Lax Tablets are available as follows:
500 mg: Off White, oval, scored tablet, debossed “CPC 339”. Available in bottles of
30 captabs (NDC 55289-949-30)
Package Label.Principal Display Panel
Fiber-Lax
* Please review the disclaimer below.