Cvs Health Natural Daily Fiber 100% Natural Psyllium Husk 160 Capsules

Cvs Health Natural Daily Fiber 100% Natural Psyllium Husk 160 Capsules
SPL v3
SPL
SPL Set ID 93f5baf1-f7c3-4e9c-ae90-cb470e3a1c51
Route
ORAL
Published
Effective Date 2020-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (0.52 g)
Inactive Ingredients
Caramel Gelatin, Unspecified Polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: FC119 Shape: capsule Color: brown Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-14

Description

Drug Facts

Purpose

Fiber Laxative


Medication Information

Purpose

Fiber Laxative

Description

Drug Facts

Uses
  • effective in treating occasional constipation and restoring regularity
Section 42229-5

Drug Facts

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.

Directions
  • Take this product 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
  • Adults 12 years and older: 5 capsules with 8 oz of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.
  • Children 12 years and under: Ask a doctor
  • Laxatives, including bulk fibers, 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.

HOW TO TAKE THIS PRODUCT

(For adults 12 years and older)

2 to 5 capsules

DIGESTIVE HEALTH

by promoting regularity

up to 4 times per day

5 capsules

HEART HEALTH by lowering cholesterol

MAINTENANCE OF HEALTHY BLOOD SUGARS LEVELS take before each meal

Allergy Alert:

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

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Other Information
  • each capsule contains: potassium 5 mg
  • capsules are sealed using a band around the middle
  • store at room temperature tightly closed to protect from humidity
  • contains a 100% natural therapeutic fiber
  • do not use if printed inner seal is broken or missing
Inactive Ingredients

caramel color, edible ink, gelatin, polysorbate 80

Questions Or Comments?

1-866-467-2748

Principal Display Panel

CVS Health ™

Compare to the active ingredient in Metamucil® capsules 3 in 1 MultiHealth Fiber ‡

Natural Daily Fiber

100% NATURAL PSYLLIUM HUSK

FIBER LAXATIVE/DIETARY SUPPLEMENT

THERAPY FOR REGULARITY

  • Helps maintain blood sugar levels as part of your diet**
  • Helps lower cholesterol to promote heart health†
  • Promotes digestive health**
  • Gluten- Free

160 CAPSULES

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

** 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 ®Capsules.

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.

Active Ingredient (in Each Capsule)

Psyllium husk approximately 0.52 g


Structured Label Content

Uses
  • effective in treating occasional constipation and restoring regularity
Section 42229-5 (42229-5)

Drug Facts

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.

Directions
  • Take this product 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
  • Adults 12 years and older: 5 capsules with 8 oz of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.
  • Children 12 years and under: Ask a doctor
  • Laxatives, including bulk fibers, 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.

HOW TO TAKE THIS PRODUCT

(For adults 12 years and older)

2 to 5 capsules

DIGESTIVE HEALTH

by promoting regularity

up to 4 times per day

5 capsules

HEART HEALTH by lowering cholesterol

MAINTENANCE OF HEALTHY BLOOD SUGARS LEVELS take before each meal

Allergy Alert: (Allergy alert:)

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

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Other Information (Other information)
  • each capsule contains: potassium 5 mg
  • capsules are sealed using a band around the middle
  • store at room temperature tightly closed to protect from humidity
  • contains a 100% natural therapeutic fiber
  • do not use if printed inner seal is broken or missing
Inactive Ingredients (Inactive ingredients)

caramel color, edible ink, gelatin, polysorbate 80

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® capsules 3 in 1 MultiHealth Fiber ‡

Natural Daily Fiber

100% NATURAL PSYLLIUM HUSK

FIBER LAXATIVE/DIETARY SUPPLEMENT

THERAPY FOR REGULARITY

  • Helps maintain blood sugar levels as part of your diet**
  • Helps lower cholesterol to promote heart health†
  • Promotes digestive health**
  • Gluten- Free

160 CAPSULES

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

** 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 ®Capsules.

Keep Out of Reach of Children (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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Psyllium husk approximately 0.52 g


Advanced Ingredient Data


Raw Label Data

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