FDA Label for Fiber Therapy Orange Flavor
View Indications, Usage & Precautions
Fiber Therapy Orange Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Kinray Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Teaspoon = 5.4 G)
Psyllium Powder 3.4 gms (approximately)
Purpose
Fiber Laxative / Fiber Supplement
Uses
Fiber Laxative
- effective in treating occasional constipation and restoring regularity
- daily fiber supplement
- for lowering cholesterol to promote heart health. Diets low in saturated fat and cholesterol that includes 7 grams of soluble fiber per day from psyllium powder, as in this product, may reduce the risk of heart disease by lowering cholesterol. One Adult dose of this product has 2.4 gms of this soluble fiber. Consult a doctor if you are considering use of this product as part of a chloesterol-lowering program.
Fiber Supplement
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
- The product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.
Allergy alert
Ask A Doctor Before Use If You Have
- a sudden change in bowel habits that persists over a period of 2 weeks
- abdominal pain, nausea, or vomiting
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, contact a doctor or a Poison Control Center right away
Directions
Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product with enough liquid may cause choking. Do not take if you have difficulty in swallowing. See choking warnings. Stir briskly and drink promptly. if mixture thickens, add more liquid and stir.
| LAXATIVE USE | DIETARY SUPPLEMENT FIBER USE | |
| Adults 12 years & older | 1 rounded teaspoon (5.4 g) in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily | 1 rounded teaspoon (5.4 g) in 8 oz. of liquid 3 times daily. |
| Children 6 years to under 12 years | 1/2 the adult dose in 8 oz. of liquid, up to 3 times daily | consult a doctor |
| Children under 6 years | consult a doctor | consult a doctor |
1. Put one dose into an empty glass2. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid.3. Taking this product without enough liquid may cause choking. See choking warining.4. Stir briskly and drink immediately. If mixture thickens, add more liquid and stir. An additional glass of liquid is recommended.
Bulk forming fibers like psyllium may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increase fiber intake, you may experience changes in bowel habits or minor bloating.
New Users: Your doctor can recommend the right dosage of this product to best meet your needs. In general, start by taking one dose a day. Gradually increase to three doses per day, if needed or recommeded by your doctor.
Other Information
- DO NOT USE THIS PRODUCT IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
- store at room temperature
- keep tightly closed to protect from humidity
- each teaspoon contains: potassium 30 mg; sodium 5 mg
Inactive Ingredients
citric acid, and maltodextrin
Product Label
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