LEADER FIBER- psyllium husk capsule 
Avera McKennan Hospital

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 Capsules

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approximately 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

Psyllium 520 mg capsule label

LEADER FIBER 
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69189-0372(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 (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:69189-0372-11 in 1 DOSE PACK; Type 0: Not a Combination Product03/06/201505/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/06/201505/24/2017
Labeler - Avera McKennan Hospital (068647668)
Establishment
NameAddressID/FEIBusiness Operations
Avera McKennan Hospital068647668relabel(69189-0372) , repack(69189-0372)

Revised: 7/2018
Document Id: 70975b78-0084-6c4e-e053-2991aa0a78bf
Set id: bafa3758-b484-4e1c-94eb-5e309618b4f8
Version: 4
Effective Time: 20180709
 
Avera McKennan Hospital