HEALTH MART FIBER  - psyllium husk powder, for suspension 
Health Mart

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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Health Mart Fiber powder Sugar free Orange flavor

Active ingredient (per each rounded teaspoon=5.8 g)

psyllium husk 3.4 g

Purpose

Bulk-forming laxative


Uses

Warnings

Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium

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
  • a sudden change in bowel habits persisting for 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Laxatives may affect how other drugs work.

When using this product

  • do not exceed the maximum recommended daily dosage in a 24-hour period
  • you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs
These could 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

New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary

adults and children 12 years and over
1 rounded teaspoon                          
6 to under 12 years
1/2 teaspoon
under 6 years
ask a doctor

Other information

Inactive ingredients

aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Fiber Supplement Information

Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program.

Warnings Read entire label, including warnings in Drug Facts

Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) in 8 oz  of liquid 3 times daily.

Children under 12 years:  Consult a doctor.

NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take  if you havbe difficulty swallowing.  See choking warning.

PDP

Health Mart Pharmacy

Compare to Metamucil®active ingredient

fiber powder

psyllium husk 3.4 g

bulk-forming laxative

dietary fiber supplement

helps maintain and restore regularity

sugar free

smooth texture

orange flavor

net wt 10 oz (283 g) 48 teaspoon dosessugar free smooth texture

HEALTH MART FIBER  
psyllium husk powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0137
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0137-1283 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/12/2012
Labeler - Health Mart (177667227)

Revised: 8/2012
Document Id: 4a145697-965e-4a46-81cc-b99535f3c132
Set id: 352b19c5-12d2-45c5-b161-0d9fdc0cdc57
Version: 1
Effective Time: 20120809
 
Health Mart