Reguloid Orange Flavor

General Statements: All Other Content

NDC 0536-4445-54

Formulation re: Other

Natural vegetable bulk-forming laxative powder & dietary fiber supplement

Formula re: Contains

Psyllium husk

Formulation re: Other

Gentle, effective relief from constipation Daily fiber source

Formulation re: Does NOT Contain

No chemical stimulants, not addictive

General Statements: All Other Content

Laxative

Formula re: Contains

Drug facts Active Ingredient (in each rounded teaspoon) Purpose Psyllium husk, approximately 3.4 g.....bulk-forming laxative

Formulation re: Other

Uses Relieves occasional constipation Generally produces bowl movement in 12-72 hours

Precautions re: All Other

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 swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Precautions re: Allergies

Allergy Alert: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium

Precautions re: All Other

Ask a doctor before use if you have A sudden change in bowel habits persisting for 2 weeks Abdominal pain, nausea, or vomiting

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: All Other

Stop use and ask doctor if Constipation lasts more than 7 days Rectal bleeding occurs These may be signs of a serious condition

Precautions re: Children

Keep out of reach of children. In case of overdose, get medical help or contact Poison control center right away.

Suggested/Recommended/Usage/Directions

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 tablespoon 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.

Formula re: Contains

Other Information Each tablespoon contains: Potassium 30 mg, sodium 5 mg

Formula re: Contains

Inactive ingredients Citric acid, FD&C yellow #6, FD&C yellow #6 lake, natural orange flavor and sucrose

FDA Statement of Identity

Dietary Fiber Supplement

Formula re: Contains

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.

Precautions re: All Other

Consult a doctor if you are considering use of this product as part of a cholesterol-lowering program.

General Statements: All Other Content

See warnings & directions in laxative section.

Suggested/Recommended/Usage/Directions

Dosage: Adults and children 12 years and over: 1 rounded tablespoon in 8 ounces of liquid, 3 times daily Children under 12 years: ask a doctor.

Precautions re: All Other

Tamper evident: Do not use if imprinted inner foil seal is broken or missing.

Storage

Store below 30 degrees C (86 degrees F). Protect contents from humidity. Keep tightly closed.