Calcium Polycarbophil 625 Mg

Calcium Polycarbophil 625 Mg
SPL v3
SPL
SPL Set ID 2fabd7ec-228f-1565-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Hypromelloses Cellulose, Microcrystalline Carob Silicon Dioxide Polyethylene Glycol 1000

Identifiers & Packaging

Pill Appearance
Imprint: AP;067 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-01

Description

Drug Facts

Purpose

Bulk-Forming Laxative


Medication Information

Purpose

Bulk-Forming Laxative

Description

Drug Facts

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5

Drug Facts

Section 50565-1

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

Drug Facts continued on back of label

Section 50566-9

Stop use and ask a doctor if

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

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 50569-3

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
Section 50570-1

Do not use longer than one week

Section 51727-6

Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide

Section 51945-4

NDC 69618-030-06

Calcium Polycarbophil 625mg

Bulk-Forming Laxative

90 Caplets

*Compare to Active Ingredient in FIBERCON®

Section 53413-1

Questions or comments? call 516-341-0666,

8:30 am - 4:30 pm ET, Monday-Friday

Warnings

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cuase 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 caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
  • take dose up to 4 times daily
  • do not take more than 8 caplets in 24 hours
  • adults & children 12 years and over: 2 caplets
  • children under 12 years: ask a doctor
Other Information
  • each caplet contains: calcium 140 mg
  • store at 15°-30°C (59°-86°F)
  • do not refrigerate
  • protect from humidity
Active Ingredient (in Each Caplet)

Calcium polycarbophil 625 mg

(equivalent to polycarbophil 500 mg)


Structured Label Content

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Drug Facts continued on back of label

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use longer than one week

Section 51727-6 (51727-6)

Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide

Section 51945-4 (51945-4)

NDC 69618-030-06

Calcium Polycarbophil 625mg

Bulk-Forming Laxative

90 Caplets

*Compare to Active Ingredient in FIBERCON®

Section 53413-1 (53413-1)

Questions or comments? call 516-341-0666,

8:30 am - 4:30 pm ET, Monday-Friday

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 cuase 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 caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
  • take dose up to 4 times daily
  • do not take more than 8 caplets in 24 hours
  • adults & children 12 years and over: 2 caplets
  • children under 12 years: ask a doctor
Other Information (Other information)
  • each caplet contains: calcium 140 mg
  • store at 15°-30°C (59°-86°F)
  • do not refrigerate
  • protect from humidity
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Calcium polycarbophil 625 mg

(equivalent to polycarbophil 500 mg)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)