Reguloid description, usages, side effects, indications, overdosage, supplying and lots more!

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Reguloid

Rugby Laboratories
Contract Pharmacal Corp

Reguloid




FULL PRESCRIBING INFORMATION

Front Panel:
Orange Flavor Reguloid®
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

(in each rounded TABLESPOON)                                 
Psyllium Husk, approximately 3.4 g

Bulk-forming Laxative

  • relieves occasional constipation
  • generally produces bowel movement in 12-72 hours

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

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea, or vomiting

taking any other drug.  Take this product two or more hours before or after other drugs.  Laxatives may affect how other drugs work.

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

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 11 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 tablespoon contains:

potassium 30 mg, sodium 5 mg

citric acid, FD&C yellow #6 lake, orange flavor and sucrose

Call 1-800-645-2158, 9 am-5 pm ET, Monday-Friday

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 2.4 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 tablespoon in 8 ounces of liquid, to 3 times daily

children under 12 years: ask a doctor

Supplement Facts
Serving Size 1 rounded tablespoon (12g)Servings per container 45
Amount Per Serving                      %DV**
Calories 45
Total Carbohydrates 12 g 4%
Dietary Fiber             3 g 12%
Soluble Fiber             2 g
Sugars                        9 g
Iron                            0.8mg 4%
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, Citric Acid, Natural Orange Flavor, FD&C Yellow #6 and FD&C Yellow #6 Lake.

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.

Rugby®
Duluth, Georgia 30097
www.rugbylaboratories.com

R0811

Reguloid

Reguloid

Psyllium POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-4445
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Psyllium Husk PSYLLIUM HUSK 3.4 g

Inactive Ingredients

Ingredient Name Strength
SUCROSE
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
maltodextrin
LACTOSE
ORANGE
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
raw sugar
CARBOXYMETHYLCELLULOSE
PROPYLENE GLYCOL ALGINATE
BUTYLATED HYDROXYANISOLE
COW MILK
ORANGE JUICE
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
BENZYL ALCOHOL

Product Characteristics

Color
ORANGE (Tan-orange)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-4445-54 368 in 1 BOTTLE
2 NDC:0536-4445-89 538 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2009-06-22


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