FIBER THERAPY ORANGE FLAVOR - psyllium dietary fiber supplement granule, for solution 
Rij Pharmaceutical Corporation

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.

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Drug Facts

Active Ingredients (in each dose)

Psyllium Hydrophilic Mucilloid 3.4 gms (approximately)

Purpose

Fiber laxative / Dietary Fiber Supplement

Uses

Fiber laxative

Dietary FIber Supplement

Warnings

Choking

Allergy alert

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.

When using this product

  • do not use more than 7 days unless directed by a doctor

Stop use and ask a doctor if

  • you experince rectal bleeding
  • you faile to have bowel movement
  • constipation persists beyond 7 days, as it may be a sign of a more serious condition.

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

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 USEDIETARY 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

citric acid, FD&C Yellow#6, flavor and Sucrose

Product Label

Outer Label

FIBER THERAPY ORANGE FLAVOR  
psyllium dietary fiber supplement granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-200
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-200-13368 g in 1 BOX; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-200)

Revised: 4/2018
Document Id: f9de8e67-438e-4793-acb3-1745ad7ab5d9
Set id: c06cfafa-d7c5-4f82-9526-68ec78536b53
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation