Cvs Health™

Cvs Health™
SPL v4
SPL
SPL Set ID 70fa9f61-c2be-4f79-8a6e-ae48311ef55b
Route
ORAL
Published
Effective Date 2020-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Acesulfame Potassium Aspartame Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-08-17

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.

6 – 11 yrs :

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

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
  • Keep out of reach of children
  • do not use if printed inner seal is broken or missing
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients:

Acesulfame potassium, aspartame, citric acid, FD&C Blue 1, FD&C Red 40,maltodextrin, natural and artificial berry flavors, silica.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

CVS Health

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

Berry

NDC 59779-934-11

Natural Daily Fiber

100% NATURAL PSYLLIUM HUSK

MULTI-BENEFIT 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

SUGAR FREE not a low calorie food

Berry

NATURALLY & ARTIFICIALLY FLAVORED

114 TEASPOONS‡

NET WT 23.3 OZ (1.4 LB) (660g)

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

GLUTEN FREE

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.

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®.

4 in 1 MultiHealth Fiber*

Distributed by: CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI 02895

© 2020 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

CVS® Quality

Money Back Guarantee

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
Purpose

Fiber therapy for regularity

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.

6 – 11 yrs :

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

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
  • Keep out of reach of children
  • do not use if printed inner seal is broken or missing
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients: (Inactive ingredients:)

Acesulfame potassium, aspartame, citric acid, FD&C Blue 1, FD&C Red 40,maltodextrin, natural and artificial berry flavors, silica.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CVS Health

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

Berry

NDC 59779-934-11

Natural Daily Fiber

100% NATURAL PSYLLIUM HUSK

MULTI-BENEFIT 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

SUGAR FREE not a low calorie food

Berry

NATURALLY & ARTIFICIALLY FLAVORED

114 TEASPOONS‡

NET WT 23.3 OZ (1.4 LB) (660g)

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

GLUTEN FREE

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.

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®.

4 in 1 MultiHealth Fiber*

Distributed by: CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI 02895

© 2020 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

CVS® Quality

Money Back Guarantee

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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