SPL v10
SPL
SPL Set ID 730198a5-b6d9-4fc7-b053-a7c65a93c540
Route
ORAL
Published
Effective Date 2020-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Caramel Crospovidone, Unspecified Hypromelloses Talc Magnesium Stearate Cellulose, Microcrystalline Light Mineral Oil Polyethylene Glycol 400 Silicon Dioxide Sodium Lauryl Sulfate Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: CPC;339 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-01

Description

Active ingredient (in each captab) Calcium polycarbophil 625 mg

Purpose

Bulk-Forming Laxative (equivalent to polycarbophil 500 mg)

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)


Medication Information

Purpose

Bulk-Forming Laxative

(equivalent to polycarbophil 500 mg)

Dosage and Administration

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
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)

Description

Active ingredient (in each captab) Calcium polycarbophil 625 mg

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12 to 72 hours
Section 34088-5

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

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 51945-4

Fiber-Lax

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

Drug Facts

Active ingredient (in each captab)

Calcium polycarbophil 625 mg

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)

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

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.

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.


Structured Label Content

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12 to 72 hours
Dosage and Administration (34068-7)

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
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Fiber-Lax

Purpose

Bulk-Forming Laxative

(equivalent to polycarbophil 500 mg)

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 (Do not use)

longer than one week

Drug Facts

Active ingredient (in each captab)

Calcium polycarbophil 625 mg

16 How Supplied (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)

Inactive Ingredients (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? (Questions or comments?)

Call 1-800-645-2158

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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 (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.


Advanced Ingredient Data


Raw Label Data

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