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Guardian

Medically reviewed on January 22, 2018

Dosage form: powder, for suspension
Ingredients: PSYLLIUM HUSK 3.4g in 5.8g
Labeler: Guardian
NDC Code: 53041-405

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.

Guardian Sugar free Natural Fiber Orange flavor

Active ingredient (per each rounded teaspoon=5.8 g)

psyllium husk 3.4 g

Purpose

Bulk-forming laxative

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.

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 over1 rounded teaspoon 
 6 to under 12 years 1/2 teaspoon
 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 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)

GDC405

GUARDIAN 
psyllium husk powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-405
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
SILICON DIOXIDE 
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53041-405-11660 g in 1 CANISTER
2NDC:53041-405-48283 g in 1 CANISTER
3NDC:53041-405-72425 g in 1 CANISTER
4NDC:53041-405-181044 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2001
Labeler - Guardian (119210276)

 
Guardian

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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