LEADER FIBER- psyllium husk capsule

Leader Fiber by

Drug Labeling and Warnings

Leader Fiber by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LEADER FIBER 
psyllium husk capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-372
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	0.52 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	FC119
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-372-78	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/16/2019

Labeler - Cardinal Health (097537435)