Indications and uses
- Treatment of occasional constipation to restore healthy bowel regularity
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 21:37:57
Label at a glance#
ProductMUCILIN
Active ingredientPSYLLIUM HUSK
Label structure11 sections
Dosage and administration
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 tim...
Storage and handling
One sachet contains: sodium 7 mg Store at room temperature. Contains 100% natural soluble fiber
Label contents#
Full prescribing information#
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.
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
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72430-004-01 | 2023-02-07 | C162847 | 48780-1 | f386c64a-3c80-0266-e053-dadaa90a7c1a | MUCILIN Orange |
| 72430-004-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c80-0266-e053-dadaa90a7c1a | MUCILIN Orange |
Products#
Every source-derived product name is available through these pages.
- MUCILIN
- Psyllium (Ispaghula) husk
- SUCROSE
- ANHYDROUS DEXTROSE
- SODIUM BENZOATE
- SACCHARIN SODIUM
- SILICON DIOXIDE
- FD&C YELLOW NO. 6
- ANHYDROUS CITRIC ACID
- PSYLLIUM HUSK
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72430-004 | 72430-004-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| ANHYDROUS DEXTROSE | 5SL0G7R0OK | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PSYLLIUM HUSK | 0SHO53407G | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1cf96e9a-6b4b-5d15-e063-6394a90a230a | f532bc08-0810-4a55-8196-06d3d88c6ed9 | 2024-07-11 | Warnings | f532bc08-0810-4a55-8196-06d3d88c6ed9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.