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Reguloid by A-S Medication Solutions

Medically reviewed on Oct 5, 2017

Dosage form: powder, for solution
Ingredients: PSYLLIUM HUSK 3.4g in 7g
Labeler: A-S Medication Solutions
NDC Code: 50090-0452

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 Psyllium Husk Regular Flavor

Front Panel:

Reguloid ® Regular Flavor

NATURAL VEGETABLE BULK-FORMING LAXATIVE POWDER & DIETARY SUPPLEMENT

PSYLLIUM HUSK

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

Back Panel:

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 reah 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?

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

Distributed by:
Rugby® Laboratories
31778 Enterprise Drive
Livonia, MI 48150

www.rugbylaboratories.com

R-29
Rev. 05/13

HOW SUPPLIED

Product: 50090-0452

NDC: 50090-0452-0 369 g in a BOTTLE

Psyllium
REGULOID 
psyllium powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0452(NDC:0536-4444)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
Product Characteristics
ColorBROWN (Tanish-yellow) Scoreno score
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50090-0452-0 369 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33410/29/2012
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0452)

 
A-S Medication Solutions

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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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