Magno-humphries - Fiber Laxative (54257-479)

Magno-humphries - Fiber Laxative (54257-479)
SPL v2
SPL
SPL Set ID e4a921c5-1cf7-12ca-e053-2a95a90a6e04
Route
ORAL
Published
Effective Date 2022-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: RP120 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-25

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
Section 50565-1

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.

Section 51945-4

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.

Ask 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 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
  • adults and children 12 years of age and over: 2 caplets once a day up to 4 times a day
  • children under 12 years of age: ask a doctor
Questions?

call toll-free 1-800-935-6737

Other Information
  • each caplet contains: calcium 125 mg
  • store at 20°-25°C (68°-77°F)
  • protect contents from moisture
Inactive Ingredients

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose,

polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Active Ingredient (in Each Caplet)

Calcium polycarbophil 625 mg

(Equivalent to 500 mg polycarbophil)


Structured Label Content

Uses
  • relieves occasional constipation to help restore and maintain regularity
  • 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 (1-800-222-1222) right away.

Section 51945-4 (51945-4)

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.

Ask 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 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
  • adults and children 12 years of age and over: 2 caplets once a day up to 4 times a day
  • children under 12 years of age: ask a doctor
Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • each caplet contains: calcium 125 mg
  • store at 20°-25°C (68°-77°F)
  • protect contents from moisture
Inactive Ingredients (Inactive ingredients)

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose,

polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

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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