Indications and uses
relieves occasional constipation generally produces bowel movement in 12-72 hours
Reguloid
- Manufacturer
- Rugby Laboratories
- Effective date
- 2019-03-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:29:18
Label at a glance#
ProductReguloid
Active ingredientPSYLLIUM HUSK
Label structure11 sections
Dosage and administration
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 ...
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
Drug Facts
Active ingredient (in each rounded TABLESPOON)
Psyllium Husk, approximately 3.4 g
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
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 tablespoon contains:
potassium 30 mg, sodium 5 mg
Inactive ingredients
citric acid, FD&C yellow #6, FD&C yellow #6 lake, orange flavor and 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 does 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 tablespoon in 8 ounces of liquid, 3 times daily
children under 12 years: ask a doctor
| Supplement Facts | |
| Serving Size 1 rounded tablespoon (12g) Servings per container 30 | |
| Amount Per Serving %DV** | |
| Calories 45 | |
| Total Carbohydrates 12 g | 4% |
| Dietary Fiber 3 g | 12% |
| Soluble Fiber 2 g | † |
| Sugars 9 g | † |
| Iron 0.8mg | 4% |
| 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, Citric Acid, Natural Orange Flavor, FD&C Yellow #6 and FD&C Yellow #6 Lake.
Store below 30˚C (86˚F). Protect contents from humidity. Keep tightly closed.
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED INNER FOIL SEAL IS BROKEN OR MISSING
Distributed By:
Rugby Laboratories
17177 N Laurel Park Drive
Suite 233
Livonia. MI 48152
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rugby ®
NDC 0536-4445-54
Orange 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. 13 oz (369 g)
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-4445-54 | GM - Gram | 0536-4445 | 4ec5bee2-0cf6-45fa-a3e7-602c62c349e7 | 1 | 2012-07-24 |
| 0536-4445-89 | GM - Gram | 0536-4445 | 7d5d6b96-1820-4351-98bf-4226566942c5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PSYLLIUM HUSK | ACTIVE INGREDIENT | 0SHO53407G | 1 | |
| PSYLLIUM HUSK | ACTIVE MOIETY | 0SHO53407G | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| CARBOXYMETHYLCELLULOSE | INACTIVE INGREDIENT | 05JZI7B19X | 1 | |
| COW MILK | INACTIVE INGREDIENT | 917J3173FT | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) | INACTIVE INGREDIENT | 461P5CJN6T | 1 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | 1 | |
| ORANGE JUICE | INACTIVE INGREDIENT | 5A9KE2L9L3 | 1 | |
| PROPYLENE GLYCOL ALGINATE | INACTIVE INGREDIENT | 26CD3J2R0C | 1 | |
| RAW SUGAR | INACTIVE INGREDIENT | 8M707QY5GH | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Reguloid
- Psyllium
- SUCROSE
- ANHYDROUS CITRIC ACID
- FD&C YELLOW NO. 6
- ORANGE
- PSYLLIUM HUSK
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0536-4445 | 0536-4445-54, 0536-4445-89 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| ORANGE | 5EVU04N5QU | IACT |
| PSYLLIUM HUSK | 0SHO53407G | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CARBOXYMETHYLCELLULOSE | CARBOXYMETHYLCELLULOSE | 05JZI7B19X | TABLET / ORAL | 45 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE, LIQUID FILLED / ORAL | 4 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / RECTAL | 1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| ORANGE JUICE | ORANGE JUICE | 5A9KE2L9L3 | SOLUTION / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION, CONCENTRATE / INTRAVENOUS | 60 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / SUBCUTANEOUS | 25 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | ADJ PH | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | ELIXIR / ORAL | 5.4 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, SUGAR COATED / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CREAM / TOPICAL | 1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 8.4 mg | ||
| CARBOXYMETHYLCELLULOSE | CARBOXYMETHYLCELLULOSE | 05JZI7B19X | SUSPENSION / ORAL | 50.07 mg/5ml | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EXTENDED RELEASE / ORAL | 400 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE / ORAL | 4 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 133 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / ORAL | 8 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL / TOPICAL | 0.08 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | GEL / TOPICAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, DELAYED RELEASE / ORAL | 160 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 620 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED PELLETS / ORAL | 135.2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / TOPICAL | 2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAVENOUS | 45 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / ORAL | 3900 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg |
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 |
|---|---|---|---|---|---|---|
| 8462d0c7-d004-6ed8-e053-2991aa0a68d7 | 5870be62-9927-4e91-bfa2-b1f4e0890202 | 2019-03-18 | Warnings | 8462d0c7-d004-6ed8-e053-2991aa0a68d7 5870be62-9927-4e91-bfa2-b1f4e0890202 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.