CALCIUM POLYCARBOPHIL tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Bulk-forming laxative relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Authorization status:
OTC monograph not final
Authorization number:
70000-0067-1

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CALCIUM POLYCARBOPHIL- calcium polycarbophil tablet, film coated

Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may

be marketed if they comply with applicable regulations and policies. FDA has not

evaluated whether this product complies.

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0339-Cardinal

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Purpose

Bulk-forming laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

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

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

*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.

LEADER

NDC 70000-0067-1

Fiver Laxative + Calcium

Calcium Polycarbophil, 625 mg

Bulk-Forming Laxative

Fiber Therapy for Regularity

COMPARE TO FIBERCON® active ingredient*

250 Caplets

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

CARAMEL (UNII: T9D99G2B1R)

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)

Cardinal Health

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 not

final

part334

11/18/2020

Labeler -

Cardinal Health (063997360)

Revised: 6/2021

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