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Name:Natural Fiber Powderorange Flavor
Manufacturer:Medline Industries, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NATURAL FIBER POWDER ORANGE FLAVOR - plantago seed powder 
Medline Industries, Inc.

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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Drug Facts

Active ingredient

Psyllium husk 3.4g (per each rounded tablespoon = 12g)

Purpose

Bulk-forming laxative

Use

  • effective in treating occasional constipation and restoring regularity

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


■ 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.
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 tablespoon in 8 ounces of liquid
6 to under 12 years: 1/2 tablespoon in 8 ounces of liquid
under 6 years: ask a doctor

Other information


  • each teaspoon contains: potassium 30 mg and sodium 5 mg
  • store at (20º-25ºC) 68º-77ºF

Inactive ingredients

citric acid, FD and C yellow No.6, natural and artificial orange flavor, sucrose


Principal Display Panel

Medline Natural Fiber Powder

100% Natural Psyllium Husk Fiber

Orange Flavor

image of ../images_otc/natural_fibe_Psyllium Husk OTCS1498C2.jpg


NATURAL FIBER POWDER  ORANGE FLAVOR
psyllium husk powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Plantago seed (Plantago seed) Plantago seed 3400 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
FD&C Yellow No. 6  
Sucrose  
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE (Orange Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-102-56 368 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/01/2009

Labeler - Medline Industries, Inc. (025460908)

Revised: 10/2009 Medline Industries, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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