Label: HEALTH MART FIBER- psyllium husk powder, for suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 62011-0137-1 - Packager: Health Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per each rounded teaspoon=5.8 g)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
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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.
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Directions
- take at the first sign of irregularity up to 3 times a day
- put one dose into an empty glass
- fill glass with 8oz of water or favorite beverage
- stir briskly and drink promptly
- if mixture thickens add more water and stir
- 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.
- if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.
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
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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
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INGREDIENTS AND APPEARANCE
HEALTH MART FIBER
psyllium husk powder, for suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0137 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 5.8 g Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0137-1 283 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/12/2012 Labeler - Health Mart (177667227)
