NATURAL FIBER POWDER ORANGE FLAVOR- psyllium husk powder

Natural Fiber Powder by

Drug Labeling and Warnings

Natural Fiber Powder by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Plantago seed (UNII: 9C60Y73166) (Plantago seed - UNII:9C60Y73166)	Plantago seed	3400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (Orange Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-102-56	368 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2009

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)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(53329-102)