Up And Up Fiber Therapy 100% Natural Psyllium Husk

Up And Up Fiber Therapy 100% Natural Psyllium Husk
SPL v9
SPL
SPL Set ID 674753ee-1174-4c06-9ed3-a090b338a39e
Route
ORAL
Published
Effective Date 2015-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Aspartame Citric Acid Monohydrate Fd&c Yellow No. 6 Maltodextrin Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-10-26

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)
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 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

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 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:

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

Questions Or Comments?

Call 1-800-910-6874

Principal Display Panel

NDC 11673-669-91

Compare to active ingredient in Metamucil® 4 in 1 MultiHealth Fiber***

fiber therapy

100% natural psyllium husk

multi-benefit daily fiber supplement therapy for regularity

helps you feel less hungry between meals**

helps maintain healthy blood sugarlevels as part of your diet **

helps lower cholesterolto promote heart health†

promotes digestive health**

sugar free

not a low calorie food

ORANGEFLAVOR 114 DOSES‡

FILL CONTROLLED BY WEIGHT NOT VOLUME

114 TEASPOON DOSES‡

NET WT 23.3 OZ (1.4 LB) 660 g

Naturally and Artificially Flavored

245 05 0216 R01 ID295403

Distributed by Target Corporation

Minneapolis, MN 55403

©2015 Target Brands, Inc.

Shop Target.com

GLUTEN FREE

**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.

†See back for information about soluble fiber and heart disease

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

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

100% satisfaction guaranteed or your money back.

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

Active Ingredient: (in Each Teaspoon)

Psyllium husk approximately 3.4 g


Structured Label Content

Uses:
  • for relief of occasional constipation (irregularity)
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 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

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 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:)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 11673-669-91

Compare to active ingredient in Metamucil® 4 in 1 MultiHealth Fiber***

fiber therapy

100% natural psyllium husk

multi-benefit daily fiber supplement therapy for regularity

helps you feel less hungry between meals**

helps maintain healthy blood sugarlevels as part of your diet **

helps lower cholesterolto promote heart health†

promotes digestive health**

sugar free

not a low calorie food

ORANGEFLAVOR 114 DOSES‡

FILL CONTROLLED BY WEIGHT NOT VOLUME

114 TEASPOON DOSES‡

NET WT 23.3 OZ (1.4 LB) 660 g

Naturally and Artificially Flavored

245 05 0216 R01 ID295403

Distributed by Target Corporation

Minneapolis, MN 55403

©2015 Target Brands, Inc.

Shop Target.com

GLUTEN FREE

**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.

†See back for information about soluble fiber and heart disease

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

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

100% satisfaction guaranteed or your money back.

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

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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