Fiber Laxative Plus Calcium (calcium Polycarbophil 625 Mg) Tablets

Fiber Laxative Plus Calcium (calcium Polycarbophil 625 Mg) Tablets
SPL v3
SPL
SPL Set ID b23dd90f-ba5a-80fc-e053-2995a90a2286
Route
ORAL
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Croscarmellose Sodium Hydrogenated Cottonseed Oil Microcrystalline Cellulose Sodium Chloride

Identifiers & Packaging

Pill Appearance
Imprint: CG006 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Active Ingredient (in each caplet) Calcium Polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Purpose

Bulk-forming Laxative


Medication Information

Purpose

Bulk-forming Laxative

Description

Active Ingredient (in each caplet) Calcium Polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

CitraGen Pharmaceuticals, Inc.,

Fremont, CA 94538.

www.citragenpharma.com

Rev. 04/25 R-00

Section 51945-4

CitraGen Pharmaceuticals, Inc.

NDC: 70369-006-08

Calcium Polycarbophil Tablets 625 mg

Fiber Laxative Plus Calcium

Calcium Polycarbophil 625 mg

Bulk-Forming Laxative

Fiber Therapy for regularity

Compare to the active ingredient in FiberCon ®

This product is not manufactured or distributed by Foundation Consumer Brands LLC, owner of the registered trademark FiberCon®

120 Caplets

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

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
  • adults and children over 12 years of age and over: take 2 caplets, 1 to 4 times per day. Do not take more than 8 caplets in one 24-hour period unless directed by a doctor.
  • children under 12 years of age: ask a doctor

Drug Facts

Active Ingredient (in each caplet)

Calcium Polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Other Information
  • each caplet contains: calcium 140 mg; sodium 14 mg
  • store in a dry place at 15° - 30°C (59° - 86°F)
  • protect contents from moisture
Inactive Ingredients

Croscarmellose Sodium NF, Hydrogenated Vegetable Oil NF, Microcrystalline Cellulose NF and Sodium Chloride USP

Questions Or Comments?

Phone: +1-510-249-9066, 9AM-5PM PST, Mon-Fri; e-mail: [email protected]

When Using This Product
  • do not use for more than 7 days unless directed by a doctor
Stop Use and Ask A Doctor If
  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • abdominal pain, nausea, or vomiting
  • difficulty in swallowing
  • 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.

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

CitraGen Pharmaceuticals, Inc.,

Fremont, CA 94538.

www.citragenpharma.com

Rev. 04/25 R-00

Section 51945-4 (51945-4)

CitraGen Pharmaceuticals, Inc.

NDC: 70369-006-08

Calcium Polycarbophil Tablets 625 mg

Fiber Laxative Plus Calcium

Calcium Polycarbophil 625 mg

Bulk-Forming Laxative

Fiber Therapy for regularity

Compare to the active ingredient in FiberCon ®

This product is not manufactured or distributed by Foundation Consumer Brands LLC, owner of the registered trademark FiberCon®

120 Caplets

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

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
  • adults and children over 12 years of age and over: take 2 caplets, 1 to 4 times per day. Do not take more than 8 caplets in one 24-hour period unless directed by a doctor.
  • children under 12 years of age: ask a doctor

Drug Facts

Active Ingredient (in each caplet)

Calcium Polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Other Information (Other information)
  • each caplet contains: calcium 140 mg; sodium 14 mg
  • store in a dry place at 15° - 30°C (59° - 86°F)
  • protect contents from moisture
Inactive Ingredients

Croscarmellose Sodium NF, Hydrogenated Vegetable Oil NF, Microcrystalline Cellulose NF and Sodium Chloride USP

Questions Or Comments? (Questions or comments?)

Phone: +1-510-249-9066, 9AM-5PM PST, Mon-Fri; e-mail: [email protected]

When Using This Product (When using this product)
  • do not use for more than 7 days unless directed by a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea, or vomiting
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are (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.

Advanced Ingredient Data


Raw Label Data

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