LEADER FIBER- calcium polycarbophil tablet, film coated 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Fiber Caplets Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg

Purpose

Bulk-forming laxative

Uses

relieves:

constipation
helps restore & maintain regularity
promotes normal function of the bowel

Warnings

Do not use if

you have abdominal pain, nausea or vomiting
you have difficulty in swallowing
you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.

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
symptoms persist more than 1 week

Drug interaction precaution: Contains calcium. If you are taking any form of tetracycline antibiotic, this product should be taken 1 hour before or 2 hours after you have taken the antibiotic

Keep out of reach of children.

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

Directions

take this product (child or adult dose) with a full glass of water (8oz)
daily maximum 4 doses
dosage may 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 of age and over

2 caplets once a day

up to 4 times a day

children under 12 years

consult a physician

Other information

each caplet contains: calcium 122 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, crospovidone, hypromellose, maltodextrin, microcrystalline cellulose, magnesium stearate, methylcellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

Principal Display Panel

NDC 30205-213-75

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available

Fiber Caplets

Calcium Polycarbophil 625 mg

Fiber Laxative

Gentle Relief of Constipation

Won't Cause Gas or Bloating

Compare to Fibercon® active ingredient

 

CIN 2545440

Distributed By:

Cardinal Health

Dublin Ohio 43017

www.myleader.com

Leader Fiber Caplets Label

Leader Fiber Caplets Label

LEADER FIBER 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARAMEL (UNII: T9D99G2B1R)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorBROWN (light) Score2 pieces
ShapeCAPSULE (caplet) Size19mm
FlavorImprint Code RP120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-213-7590 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/19/2019
Labeler - Cardinal Health (097537435)

Revised: 2/2021
Document Id: b2aedccc-da3c-4adb-8e3b-14fc3e4ac42e
Set id: f1b28346-9338-4dfe-9752-002da637e239
Version: 3
Effective Time: 20210210
 
Cardinal Health