OTC Medication Information: Meijer Fiber Therapy

MEIJER FIBER THERAPY- psyllium husk powder
MEIJER DISTRIBUTION INC

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: (in each TEASPOON)

Psyllium husk approximately 3.4 g

Purpose

Bulk-forming Laxative

Uses:

for relief of occasional constipation (irregularity)
generally produces bowel movement in 12-72 hours

Warnings:

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.

Allergy alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Ask a doctor before use if you have

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

Stop use and ask a doctor if

constipation lasts more than 7 days
rectal bleeding occurs

These may 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 at 1-800-222-1222.

Directions:

Put one dose into an empty glass. Mix 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

Adults & children 12 years & older:

1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

Children 6-11 yrs :

½ adult dose in 8 oz of liquid, up to 3 times daily

Children under 6 yrs:

Consult a doctor

Bulk-forming fibers like psyllium husk may affect how well other medicines work. 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 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Other information:

each teaspoon contains: potassium 35 mg; sodium 5 mg
PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
contains a 100% natural, therapeutic fiber
store at room temperature. Keep the container tightly closed to protect from humidity

Inactive ingredients:

aspartame, citric acid, FD&C yellow 6, maltodextrin, natural and artificial orange flavor, silica.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

meijer®

NDC 41250-508-18

Compare to Metamucil® 4 in 1 Multihealth Fiber!™ fiber content*

FIBER Therapy

100% Natural Psyllium Husk

MultiHealth Daily Fiber Supplement Therapy for Regularity

Orange Smooth

Naturally and Artificially Flavored

Helps you feel less hungry between meals**
Helps maintain healthy blood sugar levels as part of your diet**
Helps lower cholesterol to promote heart health†
Promotes digestive health **
Gluten free

SUGAR FREE

not a low calorie food

180 Teaspoon

NET WT 36.8 OZ (1043 g)

FILL CONTROLLED BY WEIGHT, NOT VOLUME

PAREVE

Serving size varies See DIRECTIONS on back panel for more information.

†See back for information about soluble fiber and heart disease.

**THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 4 in 1 MultiHealth Fiber!™.

SF SUGAR FREE
GF GLUTEN FREE

GLUTEN FREE if you have specific dietary needs, you should consult your doctor before consuming this product.

This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

OUR QUALITY GUARANTEE

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544 www.meijer.com

fiber powder orange smooth psyllium husk
(click image for full-size original)
MEIJER FIBER THERAPY
psyllium husk powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-508
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK 3.4 g in 5.79 g
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
ANHYDROUS CITRIC ACID
FD&C Yellow No. 6
MALTODEXTRIN
SILICON DIOXIDE
Product Characteristics
Color BROWN (Light Yellowish) Score
Shape Size
Flavor ORANGE (natural and artifcial) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-508-18 425 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/14/2017
Labeler — MEIJER DISTRIBUTION INC (006959555)

Revised: 01/2023 MEIJER DISTRIBUTION INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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