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Reguloid by Rugby Laboratories

Medically reviewed on December 21, 2017

Dosage form: powder, for solution
Ingredients: PSYLLIUM HUSK 3.4g in 5.8g
Labeler: Rugby Laboratories
NDC Code: 0536-1875

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

1936A - Rugby

Drug Facts

Active ingredient

(in each rounded TEASPOON)

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 Poison Control Center right away.

Directions

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 & over1 rounded TEASPOON in 8 oz of liquid, up to 3 times daily.
children 6 to under 12 years1/2 adult dose in 8 oz of liquid, up to 3 times daily
children under 6 yearsask 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 30mg, sodium 5mg

Phenylketonurics: phenylalanine 25 mg

Inactive ingredients

Aspartame, citric acid, FD&C Yellow #6, FD&C Yellow #6 Lake, maltodextrin and natural orange flavor.

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 AND 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 (5.8 g) Servings per container 48
Amount Per Serving %DV**
Calories 20
Total Carbohydrates 5 g2%
Dietary Fiber 3 g12%
Soluble Fiber 2 g
Sugars 0 g
Iron 0.8 mg4%
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: Psyllium husk, maltodextrin, citric acid, natural orange flavor, aspartame, FD&C Yellow #6, FD&C Yellow #6 Lake.

Store below 30°C (86°F). Protect contents from humidity. Keep tightly closed.

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

Rev. 009/17 R-29

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1875-79

Sugar free Reguloid®

Natural Vegetable Bulk-forming laxative powder & Dietary fiber supplement

Orange Flavor

Psyllium Husk

  • Gentle, Effective Relief from Constipation
  • Daily Fiber Source
  • No Chemical Stimulants, Not Addictive

Net Wt. 10 oz (284 g)

REGULOID 
psyllium husks powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1875
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
ORANGE 
Product Characteristics
ColororangeScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1875-79284 g in 1 BOTTLE
2NDC:0536-1875-16426 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/12/2009
Labeler - Rugby Laboratories (079246066)

 
Rugby Laboratories

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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