Drug Facts
Active ingredient (in each rounded TEASPOON)
Psyllium Husks, approximately 3.4 g
Reguloid
FDA Label NDC 68788-7129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Reguloid (NDC 68788-7129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-forming Laxative
Uses
relieves occasional constipation
generally produces bowel movement in 12-72 hours
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 an 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
Ask A Doctor Or Pharmacist Before Use If You Are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop Use And Ask A Doctor If
• constipation lasts more than 7 days
• rectal bleeding occurs
These may be signs of a serious condition.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• put one dose into an empty glass
• mix this product (child or adult dose) with at least 8 ounces (oz) (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
• stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
adults & children 12 years & over | 1 rounded TEASPOON in 8 oz of liquid, up to 3 times daily |
children 6 to under 12 years | 1/2 adult dose in 8 oz of liquid, up to 3 times daily |
children under 6 years | ask a doctor |
New Users : Start with one dose per day, gradually increase to 3 doses per day as necessary.
As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
Other Information
each teaspoon contains: potassium 30 mg, sodium 5 mg
Inactive Ingredient
sucrose
Questions Or Comments?
1-800-645-2158
Dietary Fiber Supplement
Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in Reguloid, may reduce the risk of heart disease by lowering cholesterol. One adult dose of Reguloid has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as part of a cholesterol-lowering program.
SEE WARNINGS & DIRECTIONS IN LAXATIVE SECTION.
Dosage: Adults and children 12 years and over: 1 rounded teaspoon in 8 ounces of liquid, 3 times daily. Children under 12 years: ask a doctor.
Supplement Facts | |
Serving Size 1 rounded teaspoon (7g) Servings per container 77 | |
Amount Per Serving %DV** | |
Calories 25 | |
Total Carbohydrates 7 g | 2% |
Dietary Fiber 3 g | 12% |
Soluble Fiber 2 g | * |
Sugars 3 g | * |
Iron 0.4 mg | 2% |
Sodium 5 mg | <1% |
Potassium 30 mg | <1% |
**% Daily Value (DV) is based on a 2,000 calorie diet. | |
*Daily Value (DV) not established. | |
INGREDIENTS: Sucrose, Psyllium Husk
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
INNER FOIL SEAL IS BROKEN OR MISSING
Store below 30°C (86°F). Protect contents from humidity. Keep tightly closed.
Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
Re-order No. 370160
Rev. 08/17 R-29
6879-08-17
Relabeled By: Preferred Pharmaceuticals Inc.
Package Label.Principal Display Panel
Rugby®
NDC 68788-7129-3
REGULAR FLAVOR
Reguloid®
NATURAL VEGETABLE BULK-FORMING LAXATIVE POWDER & DIETARY FIBER SUPPLEMENT
PSYLLIUM HUSK
- Gentle, Effective Relief From Constipation
- Daily Fiber Source
- No Chemical Stimulants, Not Addictive
Net Wt. 19 oz
(540 g)
Relabeled By: Preferred Pharmaceuticals Inc.
* Please review the disclaimer below.
