100% Natural Psyllium Husk Original Coarse 114 Teaspoons

100% Natural Psyllium Husk Original Coarse 114 Teaspoons
SPL v3
SPL
SPL Set ID 582ca637-f3e8-48a0-b27e-ac59cf021e14
Route
ORAL
Published
Effective Date 2021-11-18
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 2019-04-15

Description

Drug Facts

Purpose

Fiber therapy for regularity


Medication Information

Purpose

Fiber therapy for regularity

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 increased to desired daily intake. You may initially experience changes in bowel 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 ounces 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 ounces 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. 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 35 mg; sodium 5 mg
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • do not use if printed inner seal is broken or missing
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients

silica, sucrose.

Principal Display Panel

exchange select

*Compare to the Fiber Content in Metamucil® 4 in 1 MultiHealth Fiber!™*

NDC 55301-511-14

Fiber Therapy

100% Natural Psyllium Husk MultiHealth Daily Fiber Supplement Therapy for Regularity.

  • 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

Original Coarse

114 TEASPOONS DOSES

NET WT 29 OZ (1.8 LBS) 822 g

  • Quality value

fill controlled by weight, not volume

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

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

TAMPER EVIDENT:DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

**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.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil®.

GLUTEN FREE (may contain trace amounts less than 20 ppm). 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.

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”

Manufactured for Military Exchanges

By: Raritan Pharmaceuticals Inc.,

8 Joanna Court,

East Brunswick, NJ 08816

Questions Or Comments ?

1-866-467-2748

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 therapy for regularity

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.

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 ounces 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 ounces 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. 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 35 mg; sodium 5 mg
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • do not use if printed inner seal is broken or missing
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients (Inactive ingredients)

silica, sucrose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

exchange select

*Compare to the Fiber Content in Metamucil® 4 in 1 MultiHealth Fiber!™*

NDC 55301-511-14

Fiber Therapy

100% Natural Psyllium Husk MultiHealth Daily Fiber Supplement Therapy for Regularity.

  • 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

Original Coarse

114 TEASPOONS DOSES

NET WT 29 OZ (1.8 LBS) 822 g

  • Quality value

fill controlled by weight, not volume

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

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

TAMPER EVIDENT:DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

**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.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil®.

GLUTEN FREE (may contain trace amounts less than 20 ppm). 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.

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”

Manufactured for Military Exchanges

By: Raritan Pharmaceuticals Inc.,

8 Joanna Court,

East Brunswick, NJ 08816

Questions Or Comments ? (Questions or comments ?)

1-866-467-2748

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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