LEADER FIBER- psyllium husk capsule 
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 100 Fiber Capsules

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approx. 0.52 g

Purpose

fiber laxative

Uses

effective in treating occasional constipation and restoring regularity

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.

Allergy alert

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Ask a doctor before use if you have

a sudden change in bowel habits persisting for 2 weeks
abdominal pain, nausea or vomiting

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

constipation lasts more than 7 days
rectal bleeding occurs

These may 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 at the first sign of irregularity
take this product (child or adult dose) 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.
adults and children 12 years of age and over: take 5 capsules with at least 8 oz. of liquid. Swallow capsules one at a time. May repeat dose up to 3 times a day.
children 12 years and under: ask a doctor

Other information

do not use if printed inner seal is torn or missing
 store at room temperature tightly closed to protect from humidity
 contains a 100% natural, therapeutic fiber
each capsule contains potassium 5 mg

Inactive ingredients

blue 1, caramel color, gelatin, polysorbate 80, shellac, sodium lauryl sulfate, titanium dioxide.

Distributed By: Cardinal Health
Dublin OH 43017

PRINCIPAL DISPLAY PANEL - 100 Capsules Label

NDC 37205-372-78

Leader Fiber Capsules

100% Natural Psyllium Fiber Laxative
Relieves Constipation/
Restores regularity

100 CAPSULES

Leader Fiber Capsules

Leader Fiber Capsules

LEADER FIBER 
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G) Psyllium Husk0.52 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARAMEL (UNII: T9D99G2B1R)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code FC119
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-372-78100 in 1 BOTTLE; Type 0: Not a Combination Product08/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/16/2019
Labeler - Cardinal Health (097537435)

Revised: 2/2021
Document Id: de255333-8199-4979-9f5d-1b32ee88cffe
Set id: 1dee6273-cb24-44e8-bf3b-1e5d86416e72
Version: 4
Effective Time: 20210205
 
Cardinal Health