REGULOID- psyllium capsule 
Rugby Laboratories

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.

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3860 - Rugby

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

Serving Size 6 Capsule

Serving per container 26

Amount per serving %DV**
Calories 10
Total Carbohydrates3 g1%
Dietary Fiber3 g11%
Soluble Fiber2 g

†
Iron0.4 mg2%
Potassium30 mg<1%

**% Daily Values (DV) are based on a 2000 calorie diet

† Daily Value not established.

Other ingredients

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

Questions or comments?

1-800-645-2158

www.rugbylaboratories.com

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

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

*Rugby Laboratories is not affiliated with the owner of the trademark Metamucil ®

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

Rugby ®

Compare to Active Ingredient in Metamucil ®

NDC 0536-1500-60

Reguloid ®

Bulk-Forming Laxative

and Dietary Fiber Supplement

160 Banded Capsules

3860-label

REGULOID 
psyllium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK0.52 g
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
Colorbrown (Light brown, banded yellow around the middle) Scoreno score
ShapeCAPSULESize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1500-60160 in 1 BOTTLE; Type 0: Not a Combination Product04/28/201011/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/28/201011/30/2019
Labeler - Rugby Laboratories (079246066)

Revised: 12/2017
Document Id: 60c7ea7a-59ef-5feb-e053-2991aa0a698e
Set id: 4a072bbd-0e43-4950-8110-9dac5739820a
Version: 2
Effective Time: 20171220
 
Rugby Laboratories