Fiber Lax description, usages, side effects, indications, overdosage, supplying and lots more!

Fiber Lax

Rugby Laboratories
Contract Pharmacal Corp

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Fiber-Lax Calcium Polycarbophil



FULL PRESCRIBING INFORMATION

Drug Facts

(in each captab)

Calcium polycarbophil 625 mg

Bulk-Forming Laxative

(equivalent to polycarbophil 500 mg)

  • relieves occasional constipation
  • generally produces bowel movement in 12 to 72 hours

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.

longer than one week

  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.

  • you have rectal bleeding
  • you fail to have a bowel movement after using this product.

These may indicate a serious condition.

In case of overdose, get medical help or contact a Poison Control 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.

  • do not take more than 4 doses in 24 hours
  • adults & children 12 years and over: 2 captabs 1 to 4 times a day
  • children under 12 years: ask a doctor

Other information

  • each captab contains: calcium 140 mg
  • store below 30˚C (86˚F) • do not refrigerate • protect from humidity

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, 9 am - 5 pm ET, Monday – Friday

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®.

Fiber-Lax is distributed by Rugby Laboratories, Inc.

Rugby®
Duluth, Georgia 30097
www. Rugbylaboratories.com

Fiber Lax

Calcium Polycarbophil TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-4306
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALCIUM POLYCARBOPHIL 625 mg

Inactive Ingredients

Ingredient Name Strength
CARAMEL
CROSPOVIDONE
HYPROMELLOSES
magnesium silicate
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
polyethylene glycol
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE (Off-white) 19 mm CPC;339 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BLISTER PACK
2 NDC:0536-4306-11 90 in 1 BOTTLE
3 NDC:0536-4306-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-09-01


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