REGULOID- psyllium powder, for solution

Reguloid by

Drug Labeling and Warnings

Reguloid by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

www.rugbylaboratories.com

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)

INGREDIENTS AND APPEARANCE

REGULOID 
psyllium powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-4445
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-4445-54	368 g in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2009	01/31/2022
2	NDC: 0536-4445-89	538 g in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2009	02/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/22/2009	02/28/2022

Labeler - Rugby Laboratories (079246066)