Fiber Laxative

Fiber Laxative
SPL v3
SPL
SPL Set ID 9d22c208-d089-8b6a-e053-2995a90ab90a
Route
ORAL
Published
Effective Date 2020-01-24
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 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: G147 Shape: oval Color: white Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-24

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 occasional constipation to help restore and maintain regularity
  • this product generally produces bowel movement in 12 to 72 hours
Warnings

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. Choking:

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, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit
  • 2 tablets once a day up to 4 times a day adults and children 12 years of age and over:
  • ask a doctor children under 12 years of age:
Questions?

call toll-free 1-800-935-6737

Other Information
  • calcium 135 mg each tablet contains:
  • store at 20°-25°C (68°-77°F)
  • protect contents from moisture
Package Labeling:

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 tablets in a 24 hour period unless directed b y 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 or have rectal bleeding. These could be signs of a serious condition.
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

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 occasional constipation to help restore and maintain regularity
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Bulk-forming laxative

Warnings

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. Choking:

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, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit
  • 2 tablets once a day up to 4 times a day adults and children 12 years of age and over:
  • ask a doctor children under 12 years of age:
Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • calcium 135 mg each tablet contains:
  • store at 20°-25°C (68°-77°F)
  • protect contents from moisture
Package Labeling:

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 tablets in a 24 hour period unless directed b y 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 or have rectal bleeding. These could be signs of a serious condition.
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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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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