CALCIUM POLYCARBOPHIL tablet, film coated

Calcium Polycarbophil by

Drug Labeling and Warnings

Calcium Polycarbophil by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

PURPOSE

Purpose

Bulk-forming laxative

Uses

relieves occasional constipation (irregularity)
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

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 two or more hours before or after other drugs. 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

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.

Directions

take this product (child or adult dose) with a full glass of water (8oz.) 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 and over: 2 caplets, 1 to 4 times per day
• children under 12 years: ask a doctor

Other information

 each caplet contains: calcium 140 mg

do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
protect contents from moisture

INACTIVE INGREDIENT

Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Fibercon®.

©2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

PRINCIPAL DISPLAY PANEL

LEADER

NDC: 70000-0067-1

Fiber Laxative + Calcium

Calcium Polycarbophil, 625 mg

Bulk-Forming Laxative

Fiber Therapy for Regularity

COMPARE TO FIBERCON® active ingredient*

250 Caplets

INGREDIENTS AND APPEARANCE

CALCIUM POLYCARBOPHIL 
calcium polycarbophil tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0067
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W)	CALCIUM POLYCARBOPHIL	625 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CARAMEL (UNII: T9D99G2B1R)

Product Characteristics
Color	white (off white)	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	CPC;339
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0067-1	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	11/18/2020

Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)