Label: QUALITY CHOICE FIBER LAXATIVE- psyllium husk capsule
- NDC Code(s): 63868-348-01
- Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- Uses
-
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.
-
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
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL - 160 Capsules Label
Quality Choice®
NDC 63868-348-01
Compare to Metamucil® Capsules‡
Fiber Capsules
Psyllium Husk
Fiber Laxative/Dietary SupplementHelps 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
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 capsuleProduct 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 Drug M007 04/18/2019 Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)