Smooth Texture Natural Fiber Powder Orange Flavor Sugar Free 72 Teaspoon Doses

Smooth Texture Natural Fiber Powder Orange Flavor Sugar Free 72 Teaspoon Doses
SPL v3
SPL
SPL Set ID 91bf1bfb-e8a4-4d00-a8ae-b5e7da49f04a
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
Aspartame Anhydrous Citric Acid Fd&c Yellow No. 6 Maltodextrin

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-05-16

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 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
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients:

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

Principal Display Panel

NDC 53943-551-72

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

SMOOTH TEXTURE

Fiber Therapy

POWDER

Fiber Laxative/Fiber Supplement

100% Natural Psyllium Husk

SUGAR FREE

NOT A LOW CALORIE FOOD

  • +
    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**

Orange Flavor

Naturally and Artificially Flavored

72 TEASPOON DOSES

NET WT 15 OZ (425 g)

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.

Distributed By:

Drug Mart-Food Fair

211 Commerce Dr.

Medina, Ohio 44256

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 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
Purpose

Fiber Laxative

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: (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
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients: (Inactive ingredients:)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 53943-551-72

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

SMOOTH TEXTURE

Fiber Therapy

POWDER

Fiber Laxative/Fiber Supplement

100% Natural Psyllium Husk

SUGAR FREE

NOT A LOW CALORIE FOOD

  • +
    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**

Orange Flavor

Naturally and Artificially Flavored

72 TEASPOON DOSES

NET WT 15 OZ (425 g)

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.

Distributed By:

Drug Mart-Food Fair

211 Commerce Dr.

Medina, Ohio 44256

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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