MUCILIN (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

Psyllium (Ispaghula) husk 2.45 g

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

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

One sachet contains: sodium 7 mg
Store at room temperature.
Contains 100% natural soluble fiber

Inactive Ingredients

Anhydrous citric acid, colloidal silicon dioxide, dextrose anhydrous, FD&C Yellow No. 6, orange flavor, saccharin sodium, sodium benzoate, sucrose

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 
psyllium (ispaghula) husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72430-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	2.45 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72430-004-01	30 in 1 BOX	01/15/2020
1		5 g in 1 POUCH; Type 0: Not a Combination Product

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(72430-004)