Label: FIBER THERAPY ORANGE FLAVOR- psyllium dietary fiber supplement granule, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-130-13 - Packager: Kinray LLC
- 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 September 28, 2014
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each teaspoon = 5.4 g)
- Purpose
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Uses
Fiber Laxative
- effective in treating occasional constipation and restoring regularity
Fiber Supplement
- 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.
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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
- The product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.
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
- 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
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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 glass
- 2.
- 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
- Inactive Ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
FIBER THERAPY ORANGE FLAVOR
psyllium dietary fiber supplement granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-130 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 5.4 g Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color ORANGE (ORANGE) Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-130-13 283 g in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/28/2014 Labeler - Kinray LLC (012574513)
