Reguloid by A-S Medication Solutions 2688 - Rugby

Reguloid by

Drug Labeling and Warnings

Reguloid by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REGULOID- psyllium powder, for solution 
A-S Medication Solutions

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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2688 - Rugby

Drug Facts

Active ingredient (in each rounded TEASPOON)

Psyllium Husks, 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.

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 teaspoon contains: potassium 30 mg, sodium 5 mg

Inactive ingredient

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 dose 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 teaspoon in 8 ounces of liquid, 3 times daily. Children under 12 years: ask a doctor.

Supplement Facts

Serving Size 1 rounded teaspoon (7g)

Servings per container 77

Amount Per Serving %DV**

Calories 25

Total Carbohydrates 7 g

2%

Dietary Fiber 3 g

12%

Soluble Fiber 2 g

*

Sugars 3 g

*

Iron 0.4 mg

2%

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

INNER FOIL SEAL IS BROKEN OR MISSING

Store below 30ºC (86ºF). Protect contents from humidity. Keep tightly closed.

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Re-order No. 370160

Rev. 08/17 R-29

6879-08-17

HOW SUPPLIED

Product: 50090-0452

Psyllium

Label Image
REGULOID 
psyllium powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-0452(NDC: 0536-4444)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorbrownScoreno score
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-0452-0369 g in 1 BOTTLE; Type 0: Not a Combination Product11/28/201401/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/22/200901/31/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0452)

Revised: 1/2020
 
A-S Medication Solutions