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NDC 70000-0067-01 Calcium Polycarbophil 625 mg/1 Details

Calcium Polycarbophil 625 mg/1

Calcium Polycarbophil is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is CALCIUM POLYCARBOPHIL.

Product Information

NDC	70000-0067
Product ID	70000-0067_e41a4808-26e4-190c-e053-2995a90ac0b7
Associated GPIs	46300020100310
GCN Sequence Number	003065
GCN Sequence Number Description	calcium polycarbophil TABLET 625 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	08342
HICL Sequence Number	001346
HICL Sequence Number Description	CALCIUM POLYCARBOPHIL
Brand/Generic	Generic
Proprietary Name	Calcium Polycarbophil
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium Polycarbophil
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	625
Active Ingredient Units	mg/1
Substance Name	CALCIUM POLYCARBOPHIL
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0067-01 (70000006701)

Pricing Information
NDC Package Code	70000-0067-1
Billing NDC	70000006701
Package	250 TABLET, FILM COATED in 1 BOTTLE (70000-0067-1)
Marketing Start Date	2020-11-18
NDC Exclude Flag	N
Price Per Unit	0.06473
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	FIBER LAXATIVE 625 MG CAPLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b4637e18-c65f-0e81-e053-2a95a90a2284 Details

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

SPL UNCLASSIFIED SECTION

Purpose

Bulk-forming laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/18/2020

Labeler - Cardinal Health (063997360)

Revised: 7/2022

Document Id: e41a4808-26e4-190c-e053-2995a90ac0b7

Set id: b4637e18-c65f-0e81-e053-2a95a90a2284

Version: 3

Effective Time: 20220718

Search by Drug Name or NDC

NDC 70000-0067-01 Calcium Polycarbophil 625 mg/1 Details

Calcium Polycarbophil 625 mg/1

Product Information

Package

Package Images

NDC 70000-0067-01 (70000006701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b4637e18-c65f-0e81-e053-2a95a90a2284 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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