Label: REGULOID- psyllium powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 68788-7129-3 - Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 0536-4444
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 30, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
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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.
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DOSAGE & ADMINISTRATION
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
- Inactive ingredient
- Questions or comments?
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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
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SPL UNCLASSIFIED SECTION
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
Relabeled By: Preferred Pharmaceuticals Inc.
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PRINCIPAL DISPLAY PANEL
Rugby®
NDC 68788-7129-3
REGULAR FLAVOR
Reguloid®
NATURAL VEGETABLE BULK-FORMING LAXATIVE POWDER & DIETARY FIBER SUPPLEMENT
PSYLLIUM HUSK
- •
- Gentle, Effective Relief From Constipation
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- Daily Fiber Source
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- No Chemical Stimulants, Not Addictive
Net Wt. 19 oz
(540 g)
Relabeled By: Preferred Pharmaceuticals Inc.
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INGREDIENTS AND APPEARANCE
REGULOID
psyllium powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7129(NDC:0536-4444) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 7 g Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color BROWN Score no score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7129-3 369 g in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/30/2018 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7129)
