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Reguloid by Rugby Laboratories

Dosage form: capsule
Ingredients: PSYLLIUM HUSK 0.52g
Labeler: Rugby Laboratories
NDC Code: 0536-1500

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.

Reguloid

Drug Facts

Active ingredient

(in each capsule)
Psyllium husk (appx. 0.52 g)

Purpose

Bulk-Forming Laxative

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 12 to 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.

Do not use

longer than one week

Ask a doctor before use if you have
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

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 •

you experience rectal bleeding

  • you fail to have a bowel movement after using this product.

    These may indicate a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 & children 12 years and over: Take 5 capsules with 8 ounces of liquid (swallow one capsule at a time) at the first sign of irregularity.  May be taken up to 3 times daily
  • children under 12 years: ask a doctor

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.

SEE WARNINGS AND DIRECTIONS IN DRUG FACTS.
Dosage: adults & children 12 years and over: 2-6 capsules.
Children under 12 years: ask a doctor.
Supplement Facts

Supplement FactsServing Size 6 capsulesServings per container 26
Amount per serving                      %DV**
Calories 10
Total Carbohydrates         3 g1%
Dietary fiber               3 g11%
Soluble fiber               2 g
Iron                      0.4 mg2%
Potassium                 30 mg<1%
**% Daily Values (DV) are based on a 2,000 calorie diet.
†Daily Value (DV) not established.

Other ingredients: Gelatin, polysorbate 80, FD&C yellow #6 Lake, potassium sorbate, citric acid and edible ink.

Store between 15˚-30˚C (59˚-86˚F).
Keep tightly closed to protect from humidity.

Questions or comments?
Call 1-800-645-2158
9 am – 5 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

R0510

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REGULOID 
psyllium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK0.52 g
Inactive Ingredients
Ingredient NameStrength
GELATIN 
POLYSORBATE 80 
FD&C YELLOW NO. 6 
POTASSIUM SORBATE 
CITRIC ACID MONOHYDRATE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POVIDONE K30 
SHELLAC 
POLYETHYLENE GLYCOL 
ISOBUTYL ALCOHOL 
ALCOHOL 
Product Characteristics
ColorBROWN (Light brown) Scoreno score
ShapeCAPSULESize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1500-60160 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/03/2010
Labeler - Rugby Laboratories (109178264)
Registrant - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 09/2011
 
Rugby Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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