FDA Label for Mucilin SF
View Indications, Usage & Precautions
Mucilin SF Product Label
The following document was submitted to the FDA by the labeler of this product Paradigm 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.
Active Ingredient
Container Pack :
Psyllium (Ispaghula) husk 3.5 g in one Teaspoonful
Sachet Pack :
Psyllium (Ispaghula) husk 3.5 g in one Sachet
Purpose
Fiber therapy for healthy bowel regularity
Uses
- Treatment of occasional constipation to restore healthy bowel regularity
Warnings
Choking: The product should be taken with at least one full glass (8 oz) of liquid. Without enough liquid it may swell and obstruct throat and esophagus and cause choking. If you have difficulty in swallowing do not take this product. In taking the product if you feel difficulty in swallowing, breathing problems, chest pain, vomiting, seek immediate medical attention.
Allergy alert: Allergic reactions may occur in those sensitive to inhaling or ingesting psyllium husk.
Consult a doctor before use:
- if you have a sudden change in bowel functions that persists for ten days or more
- if you suffer from abdominal pain, nausea or vomiting.
Discontinue and ask a doctor if
- your constipation lasts seven days or more
- you experience rectal bleeding
Either of these may be a sign of a serious medical condition.
Directions
Directions for Container pack
Mix one teaspoonful of Mucilin briskly with at least one full glass (8 oz) of water or other liquid such as fruit juice or milk and drink immediately. Take another glass of fluid. Without sufficient liquid, the natural swelling of the product may cause choking. Please see Warnings. Do not take the product just before bedtime, or while lying down.
Adults 12yrs. & older | 1 teaspoonful in 8 oz of liquid, may be taken 3 times a day. |
Children 6 - 11 yrs. | ½ of adult dose may be taken 3 times a day. |
Under 6 yrs. | Not recommended, but consult a doctor. |
New Users | Start with 1 dose per day, gradually increase to 3 as necessary. |
Product normally effects within 12 hrs. – 48 hrs.
Due to increased fiber intake you may experience minor bloating, and change in bowel routine.
Directions for Sachet pack
Mix one sachet of Mucilin briskly with at least one full glass (8 oz) of water or other liquid such as fruit juice or milk and drink immediately. Take another glass of fluid. Without sufficient liquid, the natural swelling of the product may cause choking. Please see Warnings. Do not take the product just before bedtime, or while lying down.
Adults 12yrs. & older | 1 sachet in 8 oz of liquid, may be taken 3 times a day. |
Children 6 - 11 yrs. | ½ of adult dose may be taken 3 times a day. |
Under 6 yrs. | Not recommended, but consult a doctor. |
New Users | Start with 1 dose per day, gradually increase to 3 as necessary. |
Product normally effects within 12 hrs. – 48 hrs.
Due to increased fiber intake you may experience minor bloating, and change in bowel routine.
Other Information
Container Pack :
One teaspoonful contains: sodium 6 mg
Phenylketonurics: Contains Phenylalanine (20 mg per teaspoonful)
Store at room temperature. Tightly close the bottle to protect from humidity
Contains 100% natural soluble fiber
Sachet Pack
One sachet contains: sodium 6 mg
Phenylketonurics: Contains Phenylalanine (20 mg per sachet)
Store at room temperature.
Contains 100% natural soluble fiber.
Inactive Ingredients
Acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C Yellow No. 6, mannitol, orange flavor, sodium chloride
Questions?
Questions? Call toll free: 833-MUCILIN ®
Other
Imported and Distributed by:
Paradigm Pharmaceuticals Inc.
501 Fifth Avenue, Suite 701,
New York, New York 10017, U.S.A.
Under license from:
Paradigm Pharmaceuticals Inc., U.S.A.
Manufactured by:
Berlin Pharmaceutical Industry Co., Ltd.
Bangkok, Thailand
Product Label
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