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Guardian

Guardian

Guardian Sugar free Natural Fiber Orange flavor


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (per each rounded teaspoon=5.8 g)

psyllium husk 3.4 g

Purpose

Bulk-forming laxative

Guardian Uses

  • 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.

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits persisting for 2 weeks

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

  • 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
  • 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 
 6 to under 12 years  1/2 teaspoon
 under 6 years  ask a doctor

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

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

Guardian

Compare to the active ingredient in Metamucil®

Sugar Free

Natural Fiber

Orange Flavor

Psyllium Husk

Bulk-forming laxative

Fiber Laxative

Dietary Supplement

  • Relieves Constipation
  • Restores Regularity

114 TEASPOON DOSES

Net wt 23.3oz 1.4 LBS (660 g)

GDC405Guardian

Guardian

psyllium husk POWDER, FOR SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53041-405
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Psyllium Husk PSYLLIUM HUSK 3.4 g

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
maltodextrin
SILICON DIOXIDE

Product Characteristics

Color
brown

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53041-405-11 660 in 1 CANISTER
2 NDC:53041-405-48 283 in 1 CANISTER
3 NDC:53041-405-72 425 in 1 CANISTER
4 NDC:53041-405-18 1044 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2001-01-01


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Be sure to consult your doctor before taking any medication!
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