KONSYL FIBER- calcium polycarbophil capsule

Konsyl Fiber by

Drug Labeling and Warnings

Konsyl Fiber by is a Otc medication manufactured, distributed, or labeled by Konsyl Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Calcium Polycarbophil 625 mg (equivalent to 500 mg polycarbophil)

Purpose

Bulk-forming laxative

Uses

relieves occasional constipation promotes regularity  this product generally produces a 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
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 caplets 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. This laxative works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

• adults and children 12 years of age and older: Starting dose: 2 caplets once a day Maximum dose: 2 caplets four times a day or as directed by a doctor
• children under 12 years of age: consult a doctor

Other information

each caplet contains: calcium 138 mg
store at controlled room temperature, 68°F-77°F (20°C-25°C)
protect contents from moisture 

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients:

caramel, cellulose, crospovidone, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium lauryl sulfate, stearic acid. May also contain calcium carbonate, croscarmellose sodium, maltodextrin, talc.

Package Labeling:

INGREDIENTS AND APPEARANCE

KONSYL FIBER 
calcium polycarbophil capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1889
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)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
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-color, speckled)	Score	2 pieces
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	CPC;339
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1889-01	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/01/2019

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)