FIBER CAPS- calcium polycarbophil tablet, film coated

Fiber Caps by

Drug Labeling and Warnings

Fiber Caps by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

Uses

relieves:

• constipation
• helps restore and maintain regularity
• promotes normal function of the bowel
• this product generally produces bowel movement in 12 to 72 hours
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

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
• rectal bleeding occurs

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.

• dosage will vary according to diet, exercise, previous laxative use or severity of constipation
• continued use for 1 to 3 days is normally required to provide full benefit

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

Other information

• each caplet contains: calcium 135 mg
• 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

Principal Display Panel

Compare to the active ingredient in FIBERCON

NDC: 53041-147-27

Stimulant Free

Fiber-Caps

Fiber Laxative

Calcium polycarbophil 625 mg

• Relieves constipation
• Helps Restore and Maintain Regularity

INGREDIENTS AND APPEARANCE

FIBER CAPS  
calcium polycarbophil tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-147
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARAMEL (UNII: T9D99G2B1R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white (off white with black specks)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	G147
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-147-27	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/15/2010

Labeler - Guardian Drug Company (119210276)