fiber laxative — v7

fiber laxative

4 Views

Version

v7

Effective date

September 26, 2025

Original packager

Yes

Sections captured

11

Identifiers

Document ID
3fb1cec5-7619-a98a-e063-6294a90aca37
Set ID
22e927bd-5734-424e-8870-1aaa18f1265e
Application numbers
M007
Product NDCs
68163-119
Package NDCs
68163-119-25
Original packager NDCs

Names & Manufacturers

Brand names
fiber laxative
Generic names
PSYLLIUM HUSK
Manufacturer names
Raritan Pharmaceuticals Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
PSYLLIUM HUSK
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
0SHO53407G
UPC
0368163119251

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each capsule) Psyllium husk approximately 0.52 g
Dosage And Administration (1)

Sequence 1

Directions Take this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Adults 12 years and older: 5 capsules with at least 8 ounces. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours children 12 years and under: Ask a doctor Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients caramel color, edible ink, gelatin, polysorbate 80
Indications And Usage (1)

Sequence 1

Uses effective in treating occasional constipation and restoring regularity
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 25 Capsules Label NDC 68163-119-25 Compare to the active ingredient in Metamucil ® Capsules 3 in 1 MultiHealth Fiber!™* 100% Natural Psyllium Husk Fiber Capsules Fiber Laxative/Dietary Supplement Helps maintain healthy blood sugar levels as part of your diet** Helps lower cholesterol to promote heart health† Promotes digestive health** Gluten free (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you should consult your doctor before consuming this product. †See back for information about soluble fiber and heart disease 25 Capsules Mfg. by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® Capsules 3 in1 MultiHealth Fiber!™. DRx Choice Fiber Capsules 25 Counts
Purpose (1)

Sequence 1

Purpose Fiber laxative
Spl Product Data Elements (1)

Sequence 1

fiber laxative Psyllium Husk CARAMEL GELATIN, UNSPECIFIED POLYSORBATE 80 PSYLLIUM HUSK PSYLLIUM HUSK RP119
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Storage And Handling (1)

Sequence 1

Other information each capsule contains: potassium 5 mg store at room temperature. Keep tightly closed to protect from humidity contains a 100% natural, therapeutic fiber WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
Warnings (1)

Sequence 1

Warnings Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea or vomiting Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

OpenFDA raw payload

{'application_number': ['M007'],
 'brand_name': ['fiber laxative'],
 'generic_name': ['PSYLLIUM HUSK'],
 'is_original_packager': [True],
 'manufacturer_name': ['Raritan Pharmaceuticals Inc'],
 'package_ndc': ['68163-119-25'],
 'product_ndc': ['68163-119'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3fb1cec5-7619-a98a-e063-6294a90aca37'],
 'spl_set_id': ['22e927bd-5734-424e-8870-1aaa18f1265e'],
 'substance_name': ['PSYLLIUM HUSK'],
 'unii': ['0SHO53407G'],
 'upc': ['0368163119251']}