FDA Label for Fiber Laxative
View Indications, Usage & Precautions
Fiber Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Capsule)
Psyllium husk approx. 0.52 g
Purpose
Fiber laxative
Otc - Keep Out Of Reach Of Children
Uses
relieves:
- occasional constipation
- helps restore regularity
- promotes normal function of the bowel
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.
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
When Using This Product
- it may cause an allergic reaction in people sensitive to inhaled or ingested psyllium
Stop Use And Ask A Doctor If
- you fail to have a bowel movement after use
- rectal bleeding occurs
- 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 capsules one at a time
- daily maximum 3 doses
- dosage will vary according to diet, exercise, previous laxative use or severity of constipation.
- product generally produces effect in 12-72 hours.
- 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.
| adults and children 12 years and older | 5 capsules, 1 to 3 times a day |
| children 6 to under 11 years | consider use of powder form of product |
| children under 6 years | ask a doctor |
Other Information
- do not use if printed seal under cap is torn or missing.
- 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
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.
Pdp
Sunmark
compare to Metamucil® capsules active ingredient
fiber laxative
Relieves constipation, restores regularity
dietary fiber supplement
160 capsules
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