100% Natural Psyllium Husk Original Texture 48 Teaspoons

100% Natural Psyllium Husk Original Texture 48 Teaspoons
SPL v3
SPL
SPL Set ID 7e295a5b-9c1b-44f7-8218-c46f23774056
Route
ORAL
Published
Effective Date 2021-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Silicon Dioxide Sucrose

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-05-14

Description

Drug Facts

Purpose

Fiber Laxative


Medication Information

Purpose

Fiber Laxative

Description

Drug Facts

Uses:
  • for relief of occasional constipation (irregularity)
  • Generally produces bowel movement in 12-72 hours
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

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

New Users

Start with 1 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowl habits or minor bloating, as your body adjusts to increased fiber intake.

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. Generally produces effect in 12-72 hours.

Children 6 – 11 yrs:

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

Children under 6 yrs:

Consult a doctor

Laxative, including bulk fiber, 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.

Allergy Alert:

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

Other Information
  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • store at room temperature tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients

silica, sucrose.

Principal Display Panel

DISCOUNT drug mart

FOOD FAIR

Compare to the Active Ingredient in Metamucil®*

NDC 53943-151-48

ORIGINAL TEXTURE

Fiber Therapy POWDER

Fiber Laxative/Fiber Dietary Supplement

100% Natural Psyllium Fiber

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

48 TEASPOONS DOSES

NET WT 13 OZ (368 g)

Regular Flavor

Fill controlled by weight, not volume

TAMPER EVIDENT: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®.

SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DR., MEDINA, OHIO 44256.

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

Distributed By:

Discount Drug Mart

211 Commerce Drive

Medina, Ohio 44256

www.discount-drugmart.com

Active Ingredient: (in Each Teaspoon)

Psyllium husk approximately 3.4 g


Structured Label Content

Uses:
  • for relief of occasional constipation (irregularity)
  • Generally produces bowel movement in 12-72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Purpose

Fiber Laxative

New Users

Start with 1 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowl habits or minor bloating, as your body adjusts to increased fiber intake.

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. Generally produces effect in 12-72 hours.

Children 6 – 11 yrs:

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

Children under 6 yrs:

Consult a doctor

Laxative, including bulk fiber, 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.

Allergy Alert: (Allergy alert:)

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

Other Information (Other information)
  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • store at room temperature tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients (Inactive ingredients)

silica, sucrose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DISCOUNT drug mart

FOOD FAIR

Compare to the Active Ingredient in Metamucil®*

NDC 53943-151-48

ORIGINAL TEXTURE

Fiber Therapy POWDER

Fiber Laxative/Fiber Dietary Supplement

100% Natural Psyllium Fiber

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

48 TEASPOONS DOSES

NET WT 13 OZ (368 g)

Regular Flavor

Fill controlled by weight, not volume

TAMPER EVIDENT: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®.

SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DR., MEDINA, OHIO 44256.

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

Distributed By:

Discount Drug Mart

211 Commerce Drive

Medina, Ohio 44256

www.discount-drugmart.com

Active Ingredient: (in Each Teaspoon) (Active ingredient: (in each teaspoon))

Psyllium husk approximately 3.4 g


Advanced Ingredient Data


Raw Label Data

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