OTC Medication Information: Natural Fiber Therapy Natural Laxative

NATURAL FIBER THERAPY NATURAL LAXATIVE- psyllium husk powder, for solution
Preferred Pharmaceuticals, 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 rounded TABLESPOON)

Psyllium husk approximately 3.4 g

Purpose

Bulk-forming laxative

Uses

effective in treating occasional constipation and restoring regularity.

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 accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

Put one does 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 & Childrent 12 years & over

1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity.

Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

Children 6 to under 12 years

1/2 adult dose in 8 oz of liquid, up to 3 times daily.

Children under 6 years

Consult a doctor.

Laxatives, including bulk fibers, 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. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary.

Other information

each tablespoon contains: potassium 30 mg; sodium 5 mg
store below 30ºC (86ºF)
protect contents from humidity. Keep tightly closed.

Inactive Ingredients

citric acid, fd&c yellow no. 6, fd&c yellow no. 6 lake, natural orange flavor and sucrose

Questions and Comments?

(800) 616-2471

DIETARY FIBER SUPLEMENT

Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One adult dose of this product has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as part of a cholesterol-lowering program.

Warnings Read entire label, including warnings in Drug Facts.

Directions Adults 12 years & older : 1 rounded TABLESPOON in 8 oz of liquid 3 times daily.

under 12 years : Ask a doctor. See mixing directions in Drug Facts.

Notice: Mix this product with at least 8 ounces (a full glass) of liquid. Taking without enough liquid may cause choking. Do not take if you have difficulty swallowing. See Choking Warnings.

Supplement Facts

Serving Size 1 rounded tablespoon (12g)

Servings Per Container 30

Amount Per Serving

%DV**

Calories 45

Total Carbohydrates 12 g

4%

Dietary Fiber 3 g

12%

Soluble Fiber 2 g

*

Sugars 9 g

*

Iron 0.8 mg

4%

Sodium 5mg

<1%

Potassium 30mg

<1%

**% Daily Value (DV) is based on a 2,000 Calorie Diet.

*Daily Value (DV) not established.

INGREDIENTS : sucrose, psyllium husk, citric acid, natural orange flavor, FD&C yellow No. 6 and FD&C Yellow #6 lake

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: MAJOR ® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

Re-Order No. 013236

M-29 Rev 08/17

7982-08-17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-9558

MAJOR®

Relabeled By: Preferred Pharmaceuticals Inc.

Therapy 100% natural psyllium husk fiber

Bulk forming Laxative/Dietary Fiber Supplement

Original Texture

See back for information about soluble fiber and heart disease

Naturally Flavored

Orange Flavor
30 Tablespoon Doses

Net Wt. 13 oz (368g)

Fill controlled by weight, not volume

Natural Fiber Therapy
(click image for full-size original)
NATURAL FIBER THERAPY NATURAL LAXATIVE
psyllium husk powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9558(NDC:0904-5200)
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 7 g
Inactive Ingredients
Ingredient Name Strength
SUCROSE
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color BROWN (Tanish-yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9558-3 368 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 11/14/2013
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-9558)

Revised: 11/2019 Preferred Pharmaceuticals, 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.

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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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