Label: FIBER THERAPY ORANGE FLAVOR- psyllium dietary fiber supplement granule, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-200-13 - Packager: Rij Pharmaceutical Corporation
- 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 April 30, 2018
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- Official Label (Printer Friendly)
- Active Ingredients (in each dose)
- Purpose
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Uses
Fiber laxative
- effective in treating occasional constipation and restoring and maintaining regularity. Generally produces bowel movement in 12-72 hours
- encouragement for normal elimination naturally, without chemical stimulants
Dietary FIber Supplement
- Diets low in saturated fat and cholesterol that includes 12 gms of soluble fiber per day from psyllium husk, 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.
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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
- Inhaled or ingested psyllium powder may cause allergic reaction in people sensitive to psyllium
Do not use
- laxative products when abdominal pain, nausea or vomitting are present unless directed by a doctor
- this product if you have difficulty in swallowing or have any throat problem.
Ask a doctor before use if
Laxative
- you have a sudden change in bowel habits that persists over a period of 2 weeks
Dietary Fiber Therapy
- you are considering use of this product as part of cholesterol-lowering program.
- 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
LAXATIVE USE DIETARY SUPPLEMENT FIBER USE Adults 12 years & older
1 rounded teaspoon (7gms ) in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily
1 rounded teaspoon (12 gms) 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 rounded teaspoon in 8 oz. of liquid at the first sign of irregularity.
- 2.
- Fill an 8 oz. container with cold water, juice or other liquid.
- 3.
- Sprinkle one rounded teaspoondul of powder into liquid.
- 4.
- Stir briskly and drink immediately. If mixture thickens, add more liquid and stir. An additional glass of liquid is recommended.
Usage Tips:
Laxatives, including bulk fibers, 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 boday adjusts to increase fiber intake, you may experience changes in bowel habits or minor bloating.
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. If minor gas or bloating occurs when you increrase doses, try slightly reducing the amount your are taking. This product can be taken any time of day. To establish a routine, we suggest taking it at approximately the same time each day. Also useful for the treatment of gastrointestinal disorders associated with consitipation when recommended by a 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:53807-200 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 100 g Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color BROWN Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-200-13 368 g in 1 BOX; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-200)
