Active Ingredient (In Each Capsule)
Psyllium husk approx. 0.52 g
Fiber
FDA Label NDC 67091-222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Fiber (NDC 67091-222). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-forming laxative
Uses
relieves:
- occasional constipation
- helps restore regularity
- this product generally produces bowel movement in 12-72 hours
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 an allergic reaction in people sensitive to inhaled or ingested psyllium
Ask A Doctor Before Use If You Have
- abdominal pain, nausea or vomiting
- difficulty in swallowing
- a sudden change in bowel habits that persists over a period of 2 weeks
Stop Use And Ask A Doctor If
- you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
- symptoms persist more than 1 week
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately
Directions
- take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
- swallow one capsule at a time
- daily maximum 3 doses
- dosage will vary according to diet, exercise, previous laxative use or severity of constipation.
| adults and children 12 years and older | 5 capsules, 1 to 3 times a day |
| children 6 to 11 years | consider use of powder form of product |
| children under 6 years | 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.
Other Information
- store at room temperature
- protect contents from moisture.
Inactive Ingredients
caramel color, gelatin, iron oxide, polysorbate 80, shellac
Fiber Supplement Information
Uses: An easy way to increase your daily fiber intake. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One serving of this product provides 2.4 grams of this soluble fiber. consult a doctor if you are considering use of this product as part of a cholesterol lowering program.
Warnings: Read entire label, including warnings in Drug Facts under peel-back
Directions: Adults 12 years and older: 2-6 capsules for increasing daily fiber intake; 6 capsules for cholesterol lowering use. Take this product 8oz. of liquid (swallow 1 capsule at a time) up to 3 times daily. NOTICE: Take this product atleast 8 oz . (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See choking warning.
Pdp
*Compare to the active ingredient in METAMUCIL® Capsules
Fiber Capsules
Dietary Fiber Supplement
Relieves Occasional Constipation
160 capsules
Label (Wc650)
* Please review the disclaimer below.
