MUCILIN SF (psyllium- ispaghula husk powder

MUCILIN by

Drug Labeling and Warnings

MUCILIN by is a Otc medication manufactured, distributed, or labeled by Paradigm Pharmaceuticals Inc, BERLIN PHARMACEUTICAL INDUSTRY COMPANY LIMITED - (BRANCH). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. The product should be administered to children under adult supervision; and in case of child overdose.

Contact a physician or a poison control center immediately.

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 ®

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MUCILIN  SF
psyllium (ispaghula) husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72430-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.5 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
Mannitol (UNII: 3OWL53L36A)
Anhydrous Citric Acid (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Aspartame (UNII: Z0H242BBR1)
Acesulfame Potassium (UNII: 23OV73Q5G9)
Sodium Chloride (UNII: 451W47IQ8X)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72430-003-02	30 in 1 BOX	01/15/2020
1		5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 72430-003-01	400 g in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/15/2020

Labeler - Paradigm Pharmaceuticals Inc (080044989)

Establishment
Name	Address	ID/FEI	Business Operations
BERLIN PHARMACEUTICAL INDUSTRY COMPANY LIMITED - (BRANCH)		661748158	manufacture(72430-003)