quality choice fiber capsules psyllium husk

quality choice fiber capsules psyllium husk
SPL v6
SPL
SPL Set ID 2ee637c4-c4c6-4a24-ae99-612205afd592
Route
oral
Published
Effective Date 2019-05-09
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: RP119 Shape: capsule Color: brown Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-04-18

Purpose

Fiber laxative

Description

Drug Facts


Medication Information

Uses
  • effective in treating occasional constipation and restoring regularity
Purpose

Fiber laxative

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

caramel color, edible ink, gelatin, polysorbate 80

Description

Drug Facts

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.

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.

Questions Or Comments?

1-866-467-2748

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

Principal Display Panel 160 Capsules Label

Quality Choice ®

NDC 63868-348-01

Compare to Metamucil ®Capsules

Fiber Capsules

Psyllium Husk

Fiber Laxative/Dietary Supplement

Helps lower cholesterol to promote heart health†

Promotes digestive health**

Helps maintain healthy blood sugar levels as part of your diet*

See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.

160 Capsules

Distributed by: C.D.M.A. Inc.,

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ®3 in1 MultiHealth Fiber.


Structured Label Content

Uses
  • effective in treating occasional constipation and restoring regularity
Purpose

Fiber laxative

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

caramel color, edible ink, gelatin, polysorbate 80

Section 42229-5 (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.

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.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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

Principal Display Panel 160 Capsules Label (PRINCIPAL DISPLAY PANEL - 160 Capsules Label)

Quality Choice ®

NDC 63868-348-01

Compare to Metamucil ®Capsules

Fiber Capsules

Psyllium Husk

Fiber Laxative/Dietary Supplement

Helps lower cholesterol to promote heart health†

Promotes digestive health**

Helps maintain healthy blood sugar levels as part of your diet*

See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.

160 Capsules

Distributed by: C.D.M.A. Inc.,

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ®3 in1 MultiHealth Fiber.


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