GUARDIAN- psyllium husk powder, for suspension
Guardian Drug Company

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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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 over	1 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

53041-405-114

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 MM1

GUARDIAN
psyllium husk powder, for suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53041-405
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g in 5.8 g

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53041-405-11	660 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2001	01/17/2020
2	NDC:53041-405-48	283 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2001	01/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2001	01/17/2020

Labeler - Guardian Drug Company (119210276)

Revised: 1/2020

Document Id: ffba9a4c-44d5-425c-b36e-a7daabead0f9

Set id: d7655c03-8a47-4349-940c-f51c876ebeef

Version: 4

Effective Time: 20200117

Guardian Drug Company