FIBER LAXATIVE- calcium polycarbophil tablet

Fiber Laxative by

Drug Labeling and Warnings

Fiber Laxative by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110, LLC. DBA LEADER. 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

USE(S)

• 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 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 over dose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. 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 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 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

LEADER
NDC: 70000-0432-1

Fiber
Laxative
Calcium Polycarbophil, 625mg
Bulk-Forming Laxative 

Relieves Occasional Constipation

COMPARE TO FIBERCON® active ingredient*

250 CAPLETS

INGREDIENTS AND APPEARANCE

FIBER LAXATIVE 
calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0432
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, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	WHITE (Off white)	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	G147
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0432-1	250 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	07/24/2019

Labeler - Cardinal Health (097537435)