Gc 449(459)

Gc 449(459)
SPL v8
SPL
SPL Set ID 616b4399-7626-5e59-e053-2a91aa0a0f75
Route
ORAL
Published
Effective Date 2013-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: CPC;339 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-01-01

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
  • promotes regularity
  • this product generally produces a 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 right away.

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.

A sk a doctor before use if you have

• abdominal pain, nausea, or vomiting

• 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.

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 rectal bleeding occurs or if you fail to have a bowel movement

after use of this or any other laxative. These could be signs of a serious condition.

Directions
  • take each dose of this product 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.
  • This laxative works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.
adults and children 12

years of age and older
Starting dose: 2 caplets once a day

Maximum dose: 2 caplets four times a day or as directed by a doctor
children under 12 years of age consult a doctor
Package Label

Other Information

each caplet contains: calcium 140 mg

• store at controlled room temperature, 68°F-77°F (20°C-25°C)

• protect contents from moisture

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive Ingredients

caramel, cellulose, crospovidone, hypromellose,

magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium

lauryl sulfate, stearic acid

Active Ingredient (in Each Caplet)

Calcium Polycarbophil 625 mg

(equivalent to 500 mg polycarbophil)


Structured Label Content

Uses
  • relieves occasional constipation
  • promotes regularity
  • this product generally produces a 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 right away.

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.

A sk a doctor before use if you have

• abdominal pain, nausea, or vomiting

• 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.

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 rectal bleeding occurs or if you fail to have a bowel movement

after use of this or any other laxative. These could be signs of a serious condition.

Directions
  • take each dose of this product 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.
  • This laxative works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.
adults and children 12

years of age and older
Starting dose: 2 caplets once a day

Maximum dose: 2 caplets four times a day or as directed by a doctor
children under 12 years of age consult a doctor
Package Label

Other Information (Other information)

each caplet contains: calcium 140 mg

• store at controlled room temperature, 68°F-77°F (20°C-25°C)

• protect contents from moisture

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive Ingredients (Inactive ingredients)

caramel, cellulose, crospovidone, hypromellose,

magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium

lauryl sulfate, stearic acid

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Calcium Polycarbophil 625 mg

(equivalent to 500 mg polycarbophil)


Advanced Ingredient Data


Raw Label Data

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