FIBER LAXATIVE- psyllium husk capsule 
McKesson

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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Sunmark Fiber Laxative

Active ingredient (in each capsule)

Psyllium husk approx. 0.52 g

Purpose

Fiber laxative


Uses

relieves:

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

When using this product

  • it may cause an allergic reaction in people sensitive to inhaled or ingested psyllium

Stop use and ask a doctor if

  • you fail to have a bowel movement after use
  • rectal bleeding occurs
  • symptoms persist more than 1 week
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Directions

adults and children 12 years and older5 capsules, 1 to 3 times a day
children 6 to under 11 yearsconsider use of powder form of product
children under 6 yearsask a doctor

Other information

Inactive ingredients

caramel color, gelatin, iron oxide, polysorbate 80, shellac

Fiber Supplement information

Uses: An easy way to increase your daily fiber intake. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering  cholesterol. One serving of this product provides 2.4 grams of this soluble  fiber. consult a doctor if you are considering use of this product as part of a cholesterol lowering program.

Warnings: Read entire label, including warnings in Drug Facts

Directions: Adults 12 years and older: 2-6 capsules for increasing daily fiber intake;  6 capsules for cholesterol lowering use. Take this product 8oz. of liquid (swallow 1 capsule at a  time)  up to 3 times daily.  NOTICE:  Take this product atleast  8 oz . (a full glass) of liquid. Taking this product without enough liquid may cause choking.  Do not take if you have difficulty swallowing.

PDP

Sunmark

compare to Metamucil® capsules active ingredient

fiber laxative

Relieves constipation, restores regularity

dietary fiber supplement

160 capsulesPDP

PEELBACK

FIBER LAXATIVE 
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-633
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK520 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
GELATIN (UNII: 2G86QN327L)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
Colorwhite (Clear transparent pale to buff color) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-633-49160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/14/2003
Labeler - McKesson (177667227)

Revised: 4/2014
Document Id: ce441faa-49d4-45fb-a13d-ea6396db77c8
Set id: 76177615-d98f-482a-afe6-fdc8ea53f55f
Version: 1
Effective Time: 20140410
 
McKesson