Fiber-caps

Fiber-caps
SPL v5
SPL
SPL Set ID 31e6b0c7-1d4a-4660-ae87-9d18e0001dcd
Route
ORAL
Published
Effective Date 2024-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G147 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-07-15

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

Uses

relieves:

  • constipation
  • helps restore and maintain regularity
  • promotes normal function of the bowel
  • this product generally produces bowel movement in 12 to 72 hours

Section 50565-1

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

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




adults and children over 12 years

2 caplets, 1 to 4 times a day

children under 12 years

ask a doctor



Other Information
  • each caplet contains: calcium 135 mg
  • 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

Principal Display Panel

Compare to the active ingredient in FIBERCON

NDC 53041-147-27

Stimulant Free

Fiber-Caps

Fiber Laxative

Calcium polycarbophil 625 mg

  • Relieves constipation
  • Helps Restore and Maintain Regularity

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

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
  • rectal bleeding occurs


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

Uses

relieves:

  • constipation
  • helps restore and maintain regularity
  • promotes normal function of the bowel
  • this product generally produces bowel movement in 12 to 72 hours

Section 50565-1 (50565-1)

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

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




adults and children over 12 years

2 caplets, 1 to 4 times a day

children under 12 years

ask a doctor



Other Information (Other information)
  • each caplet contains: calcium 135 mg
  • 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

Principal Display Panel

Compare to the active ingredient in FIBERCON

NDC 53041-147-27

Stimulant Free

Fiber-Caps

Fiber Laxative

Calcium polycarbophil 625 mg

  • Relieves constipation
  • Helps Restore and Maintain Regularity

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

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
  • rectal bleeding occurs


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

All Sections (JSON)