FIBER LAXATIVE CALCIUM POLYCARBOPHIL- calcium polycarbophil tablet

Fiber Laxative Calcium Polycarbophil by

Drug Labeling and Warnings

Fiber Laxative Calcium Polycarbophil by is a Otc medication manufactured, distributed, or labeled by Magno-Humphries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MHL NDC:

54257-790-07

Compare to the active ingredient in Fibercon®*

FIBER LAXATIVE CALCIUM POLYCARBOPHIL

• RELIEVES CONSTIPATION
• 280g of CALCIUM PER DOSE
• GENTLE ENOUGH TO USE EVERDAY

90 TABLETS

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Active ingredient (in each tablet)

Calcium polycarbophil 625 mg
(Equivalent to 500 mg polycarbophil)

Purpose

Bulk-forming laxative

Uses

• relieves occasional constipation to help restore and maintain regularity
• this product 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, vomitting, 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 2 or more hours before or after other drugs. All 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 tablets in a 24 hour period unless directed by a doctor

​Stop use and ask a doctor if​ rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Keep out of reach of children.

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

Directions

• take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See chokin warning.

​Adults and children over 12 years: ​2 tablets once a day up to 4 times a day.  ​Children under 12 years:​ ask a doctor

Other information

• ​each tablet contains:​ 140 mg calcium
• store at 20° to 25°C (68° to 77°F)
• do not refrigerate
• protect from humidity

Inactive ingredients

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

Questions?

call toll-free 1-800-935-6737

*This product is not manufactured or distributed by the owener of the registered trademark Fibercon® Distributed by: Magno-Humphries, Inc., OR 97223 U.S.A. ​Visit our website: www.magno-humphries.com

*This product is not manufactured or distributed by the owener of the registered trademark Fibercon®

Distributed by: ​Magno-Humphries, Inc., OR 97223 U.S.A.

​Visit our website: www.magno-humphries.com

Package Labeling:

INGREDIENTS AND APPEARANCE

FIBER LAXATIVE CALCIUM POLYCARBOPHIL 
calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54257-790
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)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (off-white to cream)	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	CPC339
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54257-790-07	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/04/2017

Labeler - Magno-Humphries, Inc. (063251433)