Fiber Laxative

Fiber Laxative
SPL v1
SPL
SPL Set ID 507d1e11-4343-48b1-815d-2e8dd219fd9b
Route
ORAL
Published
Effective Date 2016-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Calcium Carbonate Colloidal Silicon Dioxide Crospovidone Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 1000 Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-05-05

Description

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative


Medication Information

Purpose

Bulk-forming laxative

Description

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Pdp

Compate to Fibercon active ingredient

Fiber Laxative

Calcium Polycarbophil 625mg

Fiber therapy for regularity

As effective as fiber powders

Bluk forming laxatives

140 caplets

Uses
  • relieves occasional constipation
  • 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.

Directions
  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
  • continued use for 1 or 3 days is normally required to provide full benefit.

 adults and children 12 years and over                                                                   2 caplets, 1 to 4 times a day                                            
 Children under 12 years  ask a doctor

Other Information
  • each caplet contains: calcium 135mg
  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • protect contents from moisture
Inactive Ingredients

Calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

When Using This Product
  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 caplets in a 24 hour period unless directed by a doctor.
Keep Out of Reach of Children

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

Stop use and Ask A Doctor If 
  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Active Ingredient (in Each Caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea or vomiting
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.


Structured Label Content

Pdp (PDP)

Compate to Fibercon active ingredient

Fiber Laxative

Calcium Polycarbophil 625mg

Fiber therapy for regularity

As effective as fiber powders

Bluk forming laxatives

140 caplets

Uses (uses)
  • relieves occasional constipation
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Bulk-forming laxative

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.

Directions
  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
  • continued use for 1 or 3 days is normally required to provide full benefit.

 adults and children 12 years and over                                                                   2 caplets, 1 to 4 times a day                                            
 Children under 12 years  ask a doctor

Other Information (Other information)
  • each caplet contains: calcium 135mg
  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • protect contents from moisture
Inactive Ingredients (Inactive ingredients)

Calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

When Using This Product (When using this product)
  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 caplets in a 24 hour period unless directed by a doctor.
Keep Out of Reach of Children (Keep out of reach of children)

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

Stop use and Ask A Doctor If  (Stop use and ask a doctor if )
  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea or vomiting
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 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 this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.


Advanced Ingredient Data


Raw Label Data

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