QUALITY CHOICE FIBER LAXATIVE- psyllium husk capsule

Quality Choice by

Drug Labeling and Warnings

Quality Choice by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approximately 0.52 g

Purpose

Fiber laxative

Uses

• ▪ effective in treating occasional constipation and restoring regularity

Warnings

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.

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.

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

Questions or comments?

1-866-467-2748

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.

INGREDIENTS AND APPEARANCE

QUALITY CHOICE  FIBER LAXATIVE
psyllium husk capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-348
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	0.52 g

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	RP119
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-348-01	160 in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/18/2019

Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)