CALCIUM POLYCARBOPHIL tablet

Calcium Polycarbophil by

Drug Labeling and Warnings

Calcium Polycarbophil by is a Otc medication manufactured, distributed, or labeled by CITRAGEN PHARMACEUTICALS, INC.. 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

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
• 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.

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.

Keep out of reach of children.

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

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: info@citragenpharma.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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 ®1

120 Caplets

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

PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369-006-10

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 ®2

240 Caplets

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

INGREDIENTS AND APPEARANCE

CALCIUM POLYCARBOPHIL 
calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70369-006
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	CG006
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70369-006-08	120 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025
2	NDC: 70369-006-10	240 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	07/01/2025

Labeler - CITRAGEN PHARMACEUTICALS, INC. (024949457)

Registrant - CITRAGEN PHARMACEUTICALS, INC. (024949457)

Establishment
Name	Address	ID/FEI	Business Operations
CITRAGEN PHARMACEUTICALS, INC.		024949457	manufacture(70369-006) , analysis(70369-006) , pack(70369-006) , label(70369-006)