MUCILIN

Manufacturer
Paradigm Pharmaceuticals Inc | BERLIN PHARMACEUTICAL INDUSTRY COMPANY LIMITED - (BRANCH)
Effective date
2023-02-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:37:14

Label at a glance#

ProductMUCILIN SF
Active ingredientPSYLLIUM HUSK
Label structure11 sections

Indications and uses

- Treatment of occasional constipation to restore healthy bowel regularity

Dosage and administration

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              ...

Storage and handling

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Container Pack :

Psyllium (Ispaghula) husk 3.5 g  in one Teaspoonful

Sachet Pack :

Psyllium (Ispaghula) husk 3.5 g  in one Sachet

Purpose

OTC - PURPOSE SECTION

Fiber therapy for healthy bowel regularity

Uses

INDICATIONS & USAGE SECTION

- Treatment of occasional constipation to restore healthy bowel regularity

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C Yellow No. 6, mannitol, orange flavor, sodium chloride

Questions? 

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SachetSachet

BoxBox

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72430-003-012023-02-07C16284748780-1f386c64a-2f7c-0266-e053-dadaa90a7c1aMUCILIN SF
72430-003-022023-02-07C16284748780-1f386c64a-2f7c-0266-e053-dadaa90a7c1aMUCILIN SF
72430-003-012023-01-30C16284748780-1f386c64a-2f7c-0266-e053-dadaa90a7c1aMUCILIN SF
72430-003-022023-01-30C16284748780-1f386c64a-2f7c-0266-e053-dadaa90a7c1aMUCILIN SF

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72430-00372430-003-02, 72430-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1cf93cec-2eff-5c83-e063-6394a90afedd0b1f4040-db4e-4845-ae48-afaf09ab50472024-07-11WarningsExact identifier
spl set id: 0b1f4040-db4e-4845-ae48-afaf09ab5047

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.