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care one fiber

American Sales Company

American Sales Company Fiber Laxative Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

care one fiber Uses

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

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
  • noticed 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 exceed 8 caplets in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs or you fail to have a bowel movement after use of this or any other laxative. 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 right away.

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.
  • may take one to three days to provide full benefit
  • dosage and results may vary according to diet, exercise, previous laxative use or severity of constipation
  • adults and children 12 years of age and over: 2 caplets per dose, do not exceed 4 doses per day
  • children under 12 years of age: ask a doctor

care one fiber Other information

  • each caplet contains: calcium 140 mg and magnesium 10 mg
  • store at 20°-25°C

Inactive ingredients

caramel, crospovidone, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in FiberCon®

Gentle Enough to Use Every Day

Natural Action of Fiber

Fiber Therapy for Regularity

Fiber Laxative

Bulk-Forming Fiber Laxative

Calcium Polycarbophil 625 mg

Just as Effective as Fiber Powders

care one fiber
Fiber Laxative Carton Image 1 Fiber Laxative Carton Image 2

care one fiber

Calcium polycarbophil TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-477
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALCIUM POLYCARBOPHIL 625 mg

Inactive Ingredients

Ingredient Name Strength
CARAMEL
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
SILICON DIOXIDE
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
BROWN (light) 19 mm L477 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 90 in 1 BOTTLE
2 NDC:41520-477-75 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2004-03-30


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Be sure to consult your doctor before taking any medication!
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