Natural Fiber Powder Sugar Free Orange Flavor

Dosage form: powder
Ingredients: Plantago seed 3400mg in 1g
Labeler: Medline Industries, Inc.
NDC Code: 53329-101

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 Facts

Active ingredient

Psyllium husk 3.4g (per each rounded teaspoon = 5.8g)

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

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

Inactive ingredients

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


Principal Display Panel

Medline Natural Fiber Powder

100% Natural Psyllium Husk Fiber

Sugar Free Orange Flavor

NATURAL FIBER POWDER  SUGAR FREE ORANGE FLAVOR
psyllium husk powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Plantago seed (Plantago seed) Plantago seed3400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aspartame 
Citric Acid Monohydrate 
FD&C Yellow No. 6 
Maltodextrin 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53329-101-55283 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2009
Labeler - Medline Industries, Inc. (025460908)

Revised: 10/2009
 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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