FIBER LAXATIVE- calcium polycarbophil tablet

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil
Purpose

Bulk-forming laxative
uses
- relieves occasional constipation
- 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, 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 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

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 immediately.

Directions

take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
continued use for 1 or 3 days is normally required to provide full benefit.


adults and children 12 years and over	2 caplets, 1 to 4 times a day
Children under 12 years	ask a doctor

Other information
- each caplet contains: calcium 135mg
- do not use if printed seal under cap is torn or missing
- store at room temperature
- protect contents from moisture
Inactive ingredients

Calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate
PDP

Compate to Fibercon active ingredient

Fiber Laxative

Calcium Polycarbophil 625mg

Fiber therapy for regularity

As effective as fiber powders

Bluk forming laxatives

140 caplets

INGREDIENTS AND APPEARANCE

FIBER LAXATIVE
calcium polycarbophil tablet

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
CALCIUM CARBONATE (UNII: H0G9379FGK)
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 21130-147-94	140 in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2015
2	NDC: 21130-147-27	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/05/2015

Labeler - Safeway (009137209)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(21130-147)

Fiber Laxative by