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 Raritan Pharmaceuticals Inc. 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.
Other
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
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• constipation lasts more than 7 days• rectal bleeding occurs
Stop use and ask a doctor if
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 ounces. 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• store at room temperature. Keep tightly closed to protect from humidity• contains a 100% natural, therapeutic fiber
WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
Inactive Ingredients
caramel color, edible ink, gelatin, polysorbate 80
Principal Display Panel - 25 Capsules Label
NDC 68163-119-25
Compare to the active ingredient in Metamucil® Capsules 3 in 1 MultiHealth Fiber!™*
100% Natural Psyllium Husk
Fiber Capsules
Fiber Laxative/Dietary Supplement
• Helps maintain healthy blood sugar levels as part of your diet**• Helps lower cholesterol to promote heart health†• Promotes digestive health**• Gluten free (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you should consult your doctor before consuming this product.
†See back for information about soluble fiber and heart disease
25 Capsules
Mfg. by: Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® Capsules 3 in1 MultiHealth Fiber!™.
* Please review the disclaimer below.